Identity
- Trade Name
- X-ray Film Holder EUDAMED
- Device Name
- X-ray Film Holder EUDAMED
- Model / Reference
- XH01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454002117 EUDAMED06954454010327 EUDAMED06954454001899 EUDAMED
- Basic UDI-DI
- 69544540XRFH001ZH EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
X-ray Film Holder by Huanghua Promisee Dental 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 | 69544540XRFH001ZH | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 95f5459d-43e4-4f37-a5d6-84f4b3695554 61 fields · synced Oct 7, 2026
- EUDAMED ac06488c-d433-4ee9-aad6-1dc408f06f3d 61 fields · synced May 17, 2026
- EUDAMED 8eade809-5d3b-45ed-8397-027faed9cc08 61 fields · synced May 19, 2026