Identity
- Trade Name
- Frazier EUDAMED
- Device Name
- Frazier EUDAMED
- Model / Reference
- 08-522-10-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G4380852210010 EUDAMED
- Basic UDI-DI
- ++G438085221001DU EUDAMED
- EMDN Code
- C010104 UMBILICAL I.V. CANNULAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Frazier by FHQ Trading CO. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++G438085221001DU | Class I | Active |
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Manufacturer
- Manufacturer
- FHQ Trading CO.
- EUDAMED SRN
- PK-MF-000033179
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED c5ab3330-048b-46e2-b19e-e3e4eb18d0b3 61 fields · synced Jun 18, 2026