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Head Immobilize
EUDAMEDClass I (EU MDR)
Ref HD-01Model HD-01,HD-03Ref HD-02Ref HD-03
Identity
- Device Name
- Head Immobilize EUDAMED
- Model / Reference
- HD-01,HD-03 EUDAMEDHD-01 EUDAMEDHD-02 EUDAMEDHD-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974442051019 EUDAMED06974442050708 EUDAMED06974442051026 EUDAMED
- Basic UDI-DI
- 697444205HI001B6 EUDAMED
- EMDN Code
- M030599 IMMOBILISATION SYSTEMS AND DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Immobilize by Jiangsu Rixin 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 | 697444205HI001B6 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Rixin Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008761
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED ea88f418-1fde-4fb8-accf-18b8a714b5a6 61 fields · synced Oct 5, 2026
- EUDAMED 7b67977d-4854-4997-bfab-523cbf28fc59 61 fields · synced May 17, 2026
- EUDAMED 57fc1b97-d875-4e96-8808-9b6e56865172 61 fields · synced May 18, 2026