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Peripheral Vascular Microguide Wire
EUDAMEDClass IIa (EU MDR)
Ref PGW16-165AModel PGW16-180;PGW18-180;PGW21-180;PGW16-180A;PGW18-180A;PGW21-180A;PGW16-165;PGW18-165;PGW21-165;PGW16-165A;PGW18-165A;PGW21-165A.
by Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd.
Identity
- Device Name
- Peripheral Vascular Microguide Wire EUDAMED
- Model / Reference
- PGW16-180;PGW18-180;PGW21-180;PGW16-180A;PGW18-180A;PGW21-180A;PGW16-165;PGW18-165;PGW21-165;PGW16-165A;PGW18-165A;PGW21-165A. EUDAMEDPGW16-165A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971741701096 EUDAMED
- Basic UDI-DI
- 697174170PGW0001PR EUDAMED
- Direct Marketing DI
- 06971741701096 EUDAMED
- EMDN Code
- C04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Peripheral Vascular Microguide Wire by Cardiolink Science (Shenzhen) Medical Technology Development Co., Ltd. — Class IIa — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697174170PGW0001PR | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000037464
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ba5ed2f2-22b2-4527-8622-29b2a23057e4 61 fields · synced Jun 20, 2026