Identity
- Trade Name
- Head Immobilization EUDAMED
- Device Name
- Head Immobilization EUDAMED
- Model / Reference
- TW5007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970385723280 EUDAMED
- Basic UDI-DI
- 697038572HI2D EUDAMED
- EMDN Code
- P09018099 SHOULDER PROSTHESES - ACCESSORIES - 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 Immobilization by Xiamen Tianzuo Medical 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 | 697038572HI2D | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Tianzuo Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000018733
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 2c628d24-9848-4c67-98da-27e72efd9f29 61 fields · synced Jul 23, 2026