Certification Bodies for Quality Management Systems

Transcription

1 Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Certification Bodies for Quality Management Systems according to EN ISO : AC : 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 : : Medical devices Quality management systems Requirements for regulatory purposes (ISO : 2003) + AC : 2007 List_CB_MD 1/22

2 Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH an der Technischen Universität Berlin Dovestr Berlin Phone Fax Zert@berlincert.de Website Reg.-No. ZLG-ZQ 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 /22

3 DEKRA Certification GmbH Handwerkstr Stuttgart Phone Fax Website Reg.-No. ZLG-ZQ Identification No. R 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 : node.html nnn=true List_CB_MD Date of issue 30 December /22

4 DQS Medizinprodukte GmbH August-Schanz-Str Frankfurt am Main Address for visitors Phone Fax Website Reg.-No. ZLG-ZQ Konrad-Adenauer-Allee 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 /22

5 ecm Zertifizierungsgesellschaft für Medizinprodukte in Europa mbh Bismarckstr Aachen Phone Fax Website Reg.-No. ZLG-ZQ : servicing and maintenance of active devices sterile medical devices List_CB_MD Date of issue 30 December /22

6 EUROCAT Institute for Certification and Testing GmbH Quarat Center Wittichstr Darmstadt Phone Fax kexel@eurocat.de Website Reg.-No. ZLG-ZQ 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 /22

7 Landesamt für Mess- und Eichwesen Thüringen Unterpörlitzer Str Ilmenau Phone Fax certif-thueringen@lmet.de Website Reg.-No. ZLG-ZQ 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 /22

8 LGA InterCert Zertifizierungsgesellschaft mbh Tillystr Nürnberg Phone Fax intercert@lga.de Website Reg.-No. ZLG-ZQ Identification No. R 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 : node.html nnn=true List_CB_MD Date of issue 30 December /22

9 mdc medical device certification GmbH Kriegerstr Stuttgart Phone Fax mdc@mdc-ce.de Website Reg.-No. ZLG-ZQ Identification No. R 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 : node.html nnn=true List_CB_MD Date of issue 30 December /22

10 MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH Pilatuspool Hamburg Phone Fax info@medcert.de Website Reg.-No. ZLG-ZQ Identification No. R 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 : node.html nnn=true List_CB_MD Date of issue 30 December /22

11 MPA NRW Materialprüfungsamt Nordrhein-Westfalen Marsbruchstr Dortmund Phone (486) Fax Website Reg.-No. ZLG-ZQ : analogue and digital hearing aids, audiometers List_CB_MD Date of issue 30 December /22

12 Prüf- und Forschungsinstitut Pirmasens e.v. Marie-Curie-Str Pirmasens Phone Fax info@pfi-ps.de Website Reg.-No. ZLG-ZQ medical devices in the area of orthopaedic and orthopaedic shoe laboratory technology List_CB_MD Date of issue 30 December /22

13 PÜG Prüf- und Überwachungsgesellschaft mbh In den Böden Gäufelden Phone Fax Website Reg.-No. ZLG-ZQ 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 /22

14 ruz-isulog systems-cert international certification gmbh Martin-Schmeißer-Weg Dortmund Phone Fax Website Reg.-Nr. ZLG-ZQ 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 /22

15 SLG Prüf- und Zertifizierungs GmbH Burgstädter Str Hartmannsdorf Phone Fax med@slg.de.com Website Reg.-No. ZLG-ZQ sterile medical devices restricted to devices included in the scope of accreditation List_CB_MD Date of issue 30 December /22

16 TÜV NORD CERT GmbH Langemarkstr Essen Phone Fax Website Reg.-No. ZLG-ZQ Identification No. R 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 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 : node.html nnn=true List_CB_MD Date of issue 30 December /22

17 TÜV Rheinland LGA Products GmbH Tillystr Nürnberg Contact medical devices Am Grauen Stein Köln Phone Fax service@de.tuv.com Website Reg.-No. ZLG-ZQ Identification No. R 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 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 : node.html nnn=true List_CB_MD Date of issue 30 December /22

18 TÜV SÜD Product Service GmbH Zertifizierung Medizinprodukte Ridlerstr München Phone Fax Website Reg.-No. ZLG-ZQ in vitro diagnostic medical devices sterile medical devices List_CB_MD Date of issue 30 December /22

19 VQZ Bonn e.v. Schwertberger Str Bonn - Bad Godesberg Phone Fax kontakt@vqz-bonn.de Website Reg.-No. ZLG-ZQ 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 /22

20 ZDH-ZERT GmbH Ennemoserstr Bonn Phone Fax Website Reg.-No. ZLG-ZQ 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 /22

21 Accreditation expired on March 31, 2006 TÜV NORD CERT GmbH & Co. KG Am TÜV Hannover Phone Fax info.tncert@tuev-nord.de Reg.-No. ZLG-ZQ EN ISO : 2001 and EN ISO : 2001 as well as EN : 1999 for sterile medical devices Legal successor: TÜV NORD CERT GmbH, Essen. Accreditation withdrawn on September 17, 2008 isulog cert GmbH Eisenacher Str Berlin Phone Fax kontakt@isulog-certgmbh.de Website Reg.-No. ZLG-ZQ medical devices in the area of dental and orthopaedic laboratory technology List_CB_MD Date of issue 30 December /22

22 Competent authorities for Accreditation ZLG Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Sebastianstr Bonn Phone Fax zlg@zlg.nrw.de Website ZLS Zentralstelle der Länder für Sicherheitstechnik im Bayerischen Staatsministerium für Arbeit und Sozialordnung, Familie und Frauen (StMAS) Referat II 6 / ZLS Winzererstraße München Phone Fax zls@stmas.bayern.de Website List_CB_MD Date of issue 30 December /22