Identity
- Trade Name
- Head-wedge EUDAMED
- Device Name
- Head-wedge EUDAMED
- Model / Reference
- HWG001 EUDAMEDEHW0101001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430413970 EUDAMED
- Basic UDI-DI
- 694643041195801Q5 EUDAMED
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Head-wedge by Xiamen Compower Medical Tech. Co., Ltd. — 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 | 694643041195801Q5 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED c7ed8c7a-af0f-40a2-9976-48f57258964f 61 fields · synced Jun 19, 2026