Identity
- Trade Name
- Medical Splint EUDAMED
- Device Name
- Medical Splint EUDAMED
- Model / Reference
- AZ-ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973105230181 EUDAMED
- Basic UDI-DI
- 697310523SplintFA EUDAMED
- EMDN Code
- M03050201 NATURAL CAST BANDAGES AND SPLINTS 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
Medical Splint 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 | 697310523SplintFA | 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 56e8c07a-7cbb-4ed9-a9be-c2f8894978a8 61 fields · synced Oct 5, 2026