Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Certification Bodies for Quality Management Systems according to EN ISO 13485 : 2003 + AC : 2007 1 Date of issue 30 December 2009 Remark: Only certificates which have been issued by a body authorised by the Competent Authority in accreditation by ZLG/ZLS may attest the conformity of the assessed quality management system with the underlying harmonised standards in the area of the medical device legislation in a legally effective way. Only these certificates may substantiate the presumption of conformity regarding the fulfilment of legal requirements out of EC- Directives. Translation for information purposes only. The German list of certification bodies is authoritative. 1 EN ISO 13485 : 2003-7: Medical devices Quality management systems Requirements for regulatory purposes (ISO 13485 : 2003) + AC : 2007 List_CB_MD 1/22
Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH an der Technischen Universität Berlin Dovestr. 6 10587 Berlin Phone +49 30 314 25111 Fax +49 30 314 23719 E-Mail Zert@berlincert.de Website www.berlincert.de Reg.-No. ZLG-ZQ-395.07.04-46 non-sterile medical devices orthopaedic and rehabilitation devices medical devices in the area of dental and orthopaedic laboratory technology devices for stimulation surgical devices devices for disinfection and sterilisation respiratory devices, devices for oxygen therapy, devices for inhalation anaesthesia List_CB_MD Date of issue 30 December 2009 2/22
DEKRA Certification GmbH Handwerkstr. 15 70565 Stuttgart Phone +49 711 7861 2566 Fax +49 711 7861 2615 E-Mail info@dekra-certification.com Website www.dekra.de Reg.-No. ZLG-ZQ-992.00.02-46 Identification No. R0124 2 in vitro diagnostic medical devices without devices of annex II of Directive 98/79/EC but including devices for the measurement of blood sugar sterile medical devices reprocessing of medical devices up to risk classification critical C according to the recommendation of the Commission for Hospital Hygiene and Infectious Disease Prevention at the Robert Koch-Institut (RKI) and of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) regarding the hygiene requirements for the reprocessing of medical devices 3 2 The identification number applies to the accreditation of the certification body for the scope of reprocessing of medical devices. 3 Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten, Bundesgesundheitsbl.-Gesundheitsforsch.- Gesundheitsschutz 2001 44:1115-1126 http://www.rki.de/nn_226786/de/content/infekt/krankenhaushygiene/kommission/kommission node.html nnn=true List_CB_MD Date of issue 30 December 2009 3/22
DQS Medizinprodukte GmbH August-Schanz-Str. 21 60433 Frankfurt am Main Address for visitors Phone +49 69 95427 262 Fax +49 69 95427 388 E-Mail medical.devices@dqs.de Website www.dqs.de Reg.-No. ZLG-ZQ-987.99.07-46 Konrad-Adenauer-Allee 8-10 61118 Bad Vilbel in vitro diagnostic medical devices without devices of annex II of Directive 98/79/EC sterile medical devices List_CB_MD Date of issue 30 December 2009 4/22
ecm Zertifizierungsgesellschaft für Medizinprodukte in Europa mbh Bismarckstr. 106 52066 Aachen Phone +49 241 5010 34 Fax +49 241 5010 38 E-Mail ecm@medi-online.com Website www.medi-online.com Reg.-No. ZLG-ZQ-052.05.01-46 : servicing and maintenance of active devices sterile medical devices List_CB_MD Date of issue 30 December 2009 5/22
EUROCAT Institute for Certification and Testing GmbH Quarat Center Wittichstr. 2 64295 Darmstadt Phone +49 6151 500 35 0 Fax +49 6151 500 35 50 E-Mail kexel@eurocat.de Website www.eurocat.de Reg.-No. ZLG-ZQ-684.99.05-46 in vitro diagnostic medical devices without devices of annex II of Directive 98/79/EC but including devices for the measurement of blood sugar sterile medical devices List_CB_MD Date of issue 30 December 2009 6/22
Landesamt für Mess- und Eichwesen Thüringen Unterpörlitzer Str. 2 98693 Ilmenau Phone +49 3677 850 0 Fax +49 3677 850 400 E-Mail certif-thueringen@lmet.de Website www.lmet.de Reg.-No. ZLG-ZQ-957.08.01-46 monitoring devices medical scales tonometers devices for imaging utilizing non-ionizing radiation devices for radiotherapy utilizing non-ionizing radiation devices for hyperthermia except devices for laser surgery devices for stimulation non-active medical devices with measuring function: medical thermometer; medical syringes; tonometers; devices for non invasive blood pressure measurement; devices for measurement of volume and flow; monitoring devices; medical scales List_CB_MD Date of issue 30 December 2009 7/22
LGA InterCert Zertifizierungsgesellschaft mbh Tillystr. 2 90431 Nürnberg Phone +49 911 655 4161 Fax +49 911 655 4170 E-Mail intercert@lga.de Website www.lga-intercert.com Reg.-No. ZLG-ZQ-980.02.14-46 Identification No. R1275 4 in vitro diagnostic medical devices except devices listed in annex II of Directive 98/79/EC sterile medical devices reprocessing of medical devices up to risk classification critical C according to the recommendation of the Commission for Hospital Hygiene and Infectious Disease Prevention at the Robert Koch-Institut (RKI) and of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) regarding the hygiene requirements for the reprocessing of medical devices 5 4 The identification number applies to the accreditation of the certification body for the scope of reprocessing of medical devices. 5 Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten, Bundesgesundheitsbl.-Gesundheitsforsch.- Gesundheitsschutz 2001 44:1115-1126 http://www.rki.de/nn_226786/de/content/infekt/krankenhaushygiene/kommission/kommission node.html nnn=true List_CB_MD Date of issue 30 December 2009 8/22
mdc medical device certification GmbH Kriegerstr. 6 70191 Stuttgart Phone +49 711 253597 0 Fax +49 711 253597 10 E-Mail mdc@mdc-ce.de Website www.mdc-ce.de Reg.-No. ZLG-ZQ-976.00.03-46 Identification No. R0483 6 in vitro diagnostic medical devices sterile medical devices reprocessing of medical devices up to risk classification critical C according to the recommendation of the Commission for Hospital Hygiene and Infectious Disease Prevention at the Robert Koch-Institut (RKI) and of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) regarding the hygiene requirements for the reprocessing of medical devices 7 6 The identification number applies to the accreditation of the certification body for the scope of reprocessing of medical devices. 7 Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten, Bundesgesundheitsbl.-Gesundheitsforsch.- Gesundheitsschutz 2001 44:1115-1126 http://www.rki.de/nn_226786/de/content/infekt/krankenhaushygiene/kommission/kommission node.html nnn=true List_CB_MD Date of issue 30 December 2009 9/22
MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH Pilatuspool 2 20355 Hamburg Phone +49 40 226 3325 0 Fax +49 40 226 3325 15 E-Mail info@medcert.de Website www.medcert.de Reg.-No. ZLG-ZQ-983.99.02-46 Identification No. R0482 8 in vitro diagnostic medical devices sterile medical devices reprocessing of medical devices up to risk classification critical C according to the recommendation of the Commission for Hospital Hygiene and Infectious Disease Prevention at the Robert Koch-Institut (RKI) and of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) regarding the hygiene requirements for the reprocessing of medical devices 9 8 The identification number applies to the accreditation of the certification body for the scope of reprocessing of medical devices. 9 Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten, Bundesgesundheitsbl.-Gesundheitsforsch.- Gesundheitsschutz 2001 44:1115-1126 http://www.rki.de/nn_226786/de/content/infekt/krankenhaushygiene/kommission/kommission node.html nnn=true List_CB_MD Date of issue 30 December 2009 10/22
MPA NRW Materialprüfungsamt Nordrhein-Westfalen Marsbruchstr. 186 44287 Dortmund Phone +49 231 4502 324 (486) Fax +49 231 4502 501 E-Mail orlikowski@mpanrw.de Website www.mpanrw.de Reg.-No. ZLG-ZQ-339.09.11-46 : analogue and digital hearing aids, audiometers List_CB_MD Date of issue 30 December 2009 11/22
Prüf- und Forschungsinstitut Pirmasens e.v. Marie-Curie-Str. 19 66953 Pirmasens Phone +49 6331 2490 0 Fax +49 6331 2490 60 E-Mail info@pfi-ps.de Website www.pfi-ps.de Reg.-No. ZLG-ZQ-821.98.10-46 medical devices in the area of orthopaedic and orthopaedic shoe laboratory technology List_CB_MD Date of issue 30 December 2009 12/22
PÜG Prüf- und Überwachungsgesellschaft mbh In den Böden 34 71126 Gäufelden Phone +49 7032 7808-0 Fax +49 7032 7808-50 E-Mail info@pueg.de Website www.pueg.de Reg.-No. ZLG-ZQ-378.09.06-46 non sterile medical devices in the area of orthopaedic and rehabilitation laboratory technology including medical supply stores List_CB_MD Date of issue 30 December 2009 13/22
ruz-isulog systems-cert international certification gmbh Martin-Schmeißer-Weg 16 44227 Dortmund Phone +49 231 758232 Fax +49 231 759025 E-Mail info@ruz-systems.de Website www.ruz-systems.de Reg.-Nr. ZLG-ZQ-365.09.15-46 non sterile medical devices in the area of dental, orthopaedic, orthopaedic shoe and rehabilitation laboratory technology including medical supply stores as well as of hearing aids acoustics List_CB_MD Date of issue 30 December 2009 14/22
SLG Prüf- und Zertifizierungs GmbH Burgstädter Str. 20 09232 Hartmannsdorf Phone +49 3722 7323 0 Fax +49 3722 7323 99 E-Mail med@slg.de.com Website www.slg.de.com Reg.-No. ZLG-ZQ-660.01.04-46 sterile medical devices 10 10 restricted to devices included in the scope of accreditation List_CB_MD Date of issue 30 December 2009 15/22
TÜV NORD CERT GmbH Langemarkstr. 20 45141 Essen Phone +49 201 825 3456 Fax +49 201 825 3243 E-Mail medical@tuev-nord.de Website www.tuev-nord-cert.de Reg.-No. ZLG-ZQ-967.01.09-46 Identification No. R0044 11 in vitro diagnostic medical devices except devices listed in annex II of Directive 98/79/EC sterile medical devices reprocessing of medical devices up to risk classification critical C according to the recommendation of the Commission for Hospital Hygiene and Infectious Disease Prevention at the Robert Koch-Institut (RKI) and of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) regarding the hygiene requirements for the reprocessing of medical devices 12 11 The identification number applies to the accreditation of the certification body for the scope of reprocessing of medical devices. 12 Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten, Bundesgesundheitsbl.-Gesundheitsforsch.- Gesundheitsschutz 2001 44:1115-1126 http://www.rki.de/nn_226786/de/content/infekt/krankenhaushygiene/kommission/kommission node.html nnn=true List_CB_MD Date of issue 30 December 2009 16/22
TÜV Rheinland LGA Products GmbH Tillystr. 2 90431 Nürnberg Contact medical devices Am Grauen Stein 51105 Köln Phone +49 911 655 5225 Fax +49 911 655 5226 E-Mail service@de.tuv.com Website www.tuv.com Reg.-No. ZLG-ZQ-995.00.01-46 Identification No. R0197 13 in vitro diagnostic medical devices sterile medical devices reprocessing of medical devices up to risk classification critical C according to the recommendation of the Commission for Hospital Hygiene and Infectious Disease Prevention at the Robert Koch-Institut (RKI) and of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) regarding the hygiene requirements for the reprocessing of medical devices 14 13 The identification number applies to the accreditation of the certification body for the scope of reprocessing of medical devices. 14 Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten, Bundesgesundheitsbl.-Gesundheitsforsch.- Gesundheitsschutz 2001 44:1115-1126 http://www.rki.de/nn_226786/de/content/infekt/krankenhaushygiene/kommission/kommission node.html nnn=true List_CB_MD Date of issue 30 December 2009 17/22
TÜV SÜD Product Service GmbH Zertifizierung Medizinprodukte Ridlerstr. 65 80339 München Phone +49 89 5008 4477 Fax +49 89 5008 4327 E-Mail medical_devices@tuevsued.de Website www.tuev-sued.de Reg.-No. ZLG-ZQ-999.98.12-46 in vitro diagnostic medical devices sterile medical devices List_CB_MD Date of issue 30 December 2009 18/22
VQZ Bonn e.v. Schwertberger Str. 16 53177 Bonn - Bad Godesberg Phone +49 228 94319 00 Fax +49 228 94319 26 E-Mail kontakt@vqz-bonn.de Website www.vqz-bonn.de Reg.-No. ZLG-ZQ-462.08.07-46 non sterile medical devices in the area of dental and orthopaedic laboratory technology as well as of hearing aids acoustics List_CB_MD Date of issue 30 December 2009 19/22
ZDH-ZERT GmbH Ennemoserstr. 10 53119 Bonn Phone +49 228 985240 Fax +49 228 9852411 E-Mail kohl@zdh-zert.de Website www.zdh-zert.de Reg.-No. ZLG-ZQ-341-08-11-46 non sterile medical devices in the area of orthopaedic and rehabilitation laboratory technology including medical supply stores as well as of hearing aids acoustics List_CB_MD Date of issue 30 December 2009 20/22
Accreditation expired on March 31, 2006 TÜV NORD CERT GmbH & Co. KG Am TÜV 1 30519 Hannover Phone +49 511 986 0 Fax +49 511 986 2555 E-Mail info.tncert@tuev-nord.de Reg.-No. ZLG-ZQ-583.02.01-46 EN ISO 13485 : 2001 and EN ISO 13488 : 2001 as well as EN 46003 : 1999 for sterile medical devices Legal successor: TÜV NORD CERT GmbH, Essen. Accreditation withdrawn on September 17, 2008 isulog cert GmbH Eisenacher Str. 19-20 12109 Berlin Phone +49 30 70301984 Fax +49 30 70301986 E-Mail kontakt@isulog-certgmbh.de Website www.isulog-cert-gmbh.de Reg.-No. ZLG-ZQ-510.03.06-46 medical devices in the area of dental and orthopaedic laboratory technology List_CB_MD Date of issue 30 December 2009 21/22
Competent authorities for Accreditation ZLG Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Sebastianstr. 189 53115 Bonn Phone +49 228 97794 0 Fax +49 228 97794 44 E-Mail zlg@zlg.nrw.de Website www.zlg.de ZLS Zentralstelle der Länder für Sicherheitstechnik im Bayerischen Staatsministerium für Arbeit und Sozialordnung, Familie und Frauen (StMAS) Referat II 6 / ZLS Winzererstraße 9 80797 München Phone +49 89 1261 2582 Fax +49 89 1261 2550 E-Mail zls@stmas.bayern.de Website www.zls-muenchen.de List_CB_MD Date of issue 30 December 2009 22/22