Identity
- Trade Name
- Head immobilizer EUDAMED
- Device Name
- Head immobilizer EUDAMED
- Model / Reference
- DW-FA001B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977728544663 EUDAMED
- Basic UDI-DI
- 697772854DWHIVX EUDAMED
- Direct Marketing DI
- 06977728544663 EUDAMED
- EMDN Code
- M030599 IMMOBILISATION SYSTEMS AND DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 immobilizer by Suzhou Ireland Medical Equipment 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 | 697772854DWHIVX | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Ireland Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000043757
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 077fafea-99dd-40e4-ba08-bc0354f7af0d 61 fields · synced Oct 6, 2026