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Head Immobilizer
EUDAMEDClass I (EU MDR)
Ref XH-16AModel XH-16A,XH-16B ,XH-16C
by Zhangjiagang Xiehe Medical Apparatus&Instruments Co., Ltd.
Identity
- Device Name
- Head Immobilizer EUDAMED
- Model / Reference
- XH-16A,XH-16B ,XH-16C EUDAMEDXH-16A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974580871606 EUDAMED
- Basic UDI-DI
- 6974580870011DR EUDAMED
- EMDN Code
- M030599 IMMOBILISATION SYSTEMS AND DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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 (1)
- EUDAMED 3ecbaaa3-199e-4458-a68a-39ab7fe3aa73 61 fields · synced Jun 18, 2026