2023年7月7日,位于塞浦路斯的HTCert (Health Technology Certification Ltd)(公告机构编号:NB 2803)获得CE MDR审核资质,该公告机构为塞浦路斯境内的第1家CE MDR公告机构,至此CE MDR公告机构增至39家。
截至目前为止,已获得CE MDR审核资质的39家公告机构清单如下:
Body type | Body name | country |
NB 0044 | TÜV NORD CERT GmbH | Germany |
NB 0050 | National Standards Authority of Ireland (NSAI) | Ireland |
NB 0051 | IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. | Italy |
NB 0123 | TÜV SÜD Product Service GmbH | Germany |
NB 0124 | DEKRA Certification GmbH | Germany |
NB 0197 | TÜV Rheinland LGA Products GmbH | Germany |
NB 0297 | DQS Medizinprodukte GmbH | Germany |
NB 0318 | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | Spain |
NB 0344 | DEKRA Certification B.V. | Netherlands |
NB 0373 | ISTITUTO SUPERIORE DI SANITA’ | Italy |
NB 0425 | ICIM S.P.A. | Italy |
NB 0426 | ITALCERT SRL | Italy |
NB 0459 | GMED SAS | France |
NB 0476 | KIWA CERMET ITALIA S.P.A. | Italy |
NB 0477 | Eurofins Product Testing Italy S.r.l. | Italy |
NB 0482 | DNV MEDCERT GmbH | Germany |
NB 0483 | MDC MEDICAL DEVICE CERTIFICATION GMBH | Germany |
NB 0494 | SLG PRÜF UND ZERTIFIZIERUNGS GMBH | Germany |
NB 0537 | Eurofins Electric & Electronics Finland Oy | Finland |
NB 0546 | CERTIQUALITY S.r.l. | Italy |
NB 0598 ex:403 | SGS FIMKO OY | Finland |
NB 0633 | Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH | Germany |
NB 1023 | INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 | Czech Republic |
NB 1282 | ENTE CERTIFICAZIONE MACCHINE SRL | Italy |
NB 1304 | SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SIQ | Slovenia |
NB 1370 | BUREAU VERITAS ITALIA S.P.A. | Italy |
NB 1434 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Poland |
NB 1639 | SGS Belgium NV | Belgium |
NB 1912 | Kiwa Dare B.V. | Netherlands |
NB 1936 | TUV Rheinland Italia SRL | Italy |
NB 2265 | 3EC International a.s. | Slovakia |
NB 2274 | TUV NORD Polska Sp. z o.o | Poland |
NB 2409 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Hungary |
NB 2460 | DNV Product Assurance AS | Norway |
NB 2696 | UDEM Adriatic d.o.o. | Croatia |
NB 2797 | BSI Group The Netherlands B.V. | Netherlands |
NB 2803 | HTCert (Health Technology Certification Ltd) | Cyprus |
NB 2862 | Intertek Medical Notified Body AB | Sweden |
NB 2975 | SZUTEST Konformitätsbewertungsstelle GmbH | Germany |
另外,2023年9月16日,NANDO官网正式公示,Eurofins Electric & Electronics Finland Oy(公告机构编号:0537)成为欧盟体外诊断器械法规(IVDR 2017/746)公告机构,该公告机构是为数不多的拥有CE MDR资格和CE IVDR资格的公告机构之一,至此已经获得授权的CE IVDR公告机构增至11家。
截至目前为止,已获得CE IVDR审核资质的11家公告机构清单如下:
NB 0050 | National Standards Authority of Ireland (NSAI) | Ireland |
NB 0123 | TÜV SÜD Product Service GmbH | Germany |
NB 0124 | DEKRA Certification GmbH | Germany |
NB 0197 | TÜV Rheinland LGA Products GmbH | Germany |
NB 0344 | DEKRA Certification B.V. | Netherlands |
NB 0459 | GMED SAS | France |
NB 0483 | MDC MEDICAL DEVICE CERTIFICATION GMBH | Germany |
NB 0537 | Eurofins Electric & Electronics Finland Oy | Finland |
NB 2265 | 3EC International a.s. | Slovakia |
NB 2797 | BSI Group The Netherlands B.V. | Netherlands |
NB 2962 | QMD Services GmbH | Austria |
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