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Head Immobilizer
EUDAMEDClass I (EU MDR)
Ref HI-R-CModel AZ-HI01、AZ-HI-01、AZ-HI-02、AZ-HI-03、AZ-HI-05、AZ-HIA、AZ-HIA-01、AZ-HIA-02、AZ-HIA-03、AZ-HIA-04、AZ-HIS
Identity
- Trade Name
- Head Immobilizer EUDAMED
- Device Name
- Head Immobilizer EUDAMED
- Model / Reference
- AZ-HI01、AZ-HI-01、AZ-HI-02、AZ-HI-03、AZ-HI-05、AZ-HIA、AZ-HIA-01、AZ-HIA-02、AZ-HIA-03、AZ-HIA-04、AZ-HIS EUDAMEDHI-R-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973105230587 EUDAMED
- Basic UDI-DI
- 697310523AZHIHG EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - 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 Anping Guardian 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 | 697310523AZHIHG | Class I | Active |
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Manufacturer
- Manufacturer
- Anping Guardian Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000015025
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 21b1c7a6-5bd3-4e8f-a6b7-cfc7e4fdb885 61 fields · synced Jun 18, 2026