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Head Immobilizer
EUDAMEDClass I (EU MDR)
Ref XH-16CModel XH-16A,XH-16B ,XH-16CRef XH-16B
by Zhangjiagang Xiehe Medical Apparatus&Instruments Co., Ltd.
Identity
- Device Name
- Head Immobilizer EUDAMED
- Model / Reference
- XH-16A,XH-16B ,XH-16C EUDAMEDXH-16C EUDAMEDXH-16B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974580871654 EUDAMED06974580871630 EUDAMED
- Basic UDI-DI
- 6974580870011DR EUDAMED
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDFrance 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
Head Immobilizer by Zhangjiagang Xiehe Medical Apparatus&Instruments 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 | 6974580870011DR | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000008449
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 4345b114-f2b4-4a9b-b6d7-d819e117be6e 61 fields · synced Oct 6, 2026
- EUDAMED 1402d339-d97f-4aed-af4a-a7e480760e7d 61 fields · synced May 18, 2026