D005 - Vernivia Vaginal mousse

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Pharmiva AB·1 device

Javitech Consulting GmbH

Authorized representative

🇩🇪 Germany·12 Manufacturers·64 Devices

Patient Guard Europe UG

Authorized representative

🇩🇪 Germany·13 Manufacturers·10 Devices

3901646CE01

Certificate

MDD Annex II (excluding section 4)·CathWorks Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI

7406GB410210510A

Certificate

MDD Annex II (excluding section 4)·EyeYon Medical Ltd.·DNV MEDCERT GmbH·2 Basic UDI-DIs

2125546CE01

Certificate

MDD Annex II (excluding section 4)·IOPtima Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI

170222 QS/NB

Certificate

MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

OMC NI MEDICAL LIMITED

Authorized representative

13 Manufacturers·18 Devices

0106415-03

Certificate

MDD Annex III·Nanjing 3H Medical Products Co.,Ltd.·INTERTEK SEMKO AB·3 Basic UDI-DIs

41319433-05

Certificate

MDD Annex II (excluding section 4)·Cynosure LLC·INTERTEK SEMKO AB·342 Basic UDI-DIs

41371240

Certificate

MDD Annex II (excluding section 4)·X-Nav Technologies, LLC·INTERTEK SEMKO AB·4 Basic UDI-DIs

41371410

Certificate

MDD Annex II (excluding section 4)·Remote Diagnostic Technologies Ltd.·INTERTEK SEMKO AB·1 Basic UDI-DI

41311197-02_Rev.2

Certificate

MDD Annex II (excluding section 4)·Invivo, a division of Philips Medical Systems·INTERTEK SEMKO AB·15 Basic UDI-DIs

41314564

Certificate

MDD Annex II (excluding section 4)·NxStage Medical, Inc.·INTERTEK SEMKO AB·39 Basic UDI-DIs

41377383

Certificate

MDD Annex II (excluding section 4)·OsteoCare Implant System Limited·INTERTEK SEMKO AB·232 Basic UDI-DIs

41314564

Certificate

MDD Annex II (excluding section 4)·NxStage Medical, Inc.·INTERTEK SEMKO AB·7 Basic UDI-DIs

41371231-03

Certificate

MDD Annex V·Shenzhen Homed Medical Device Co., Ltd.·INTERTEK SEMKO AB·3 Basic UDI-DIs

41371231

Certificate

MDD Annex V·Shenzhen Homed Medical Device Co., Ltd.·INTERTEK SEMKO AB·1 Basic UDI-DI

413141564

Certificate

MDD Annex II (excluding section 4)·NxStage Medical, Inc.·INTERTEK SEMKO AB·1 Basic UDI-DI