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Fiberglass Splint
EUDAMEDClass I (EU MDR)
Ref a＋420（100mm×500mm）Model AX315（75mm×300mm）
Identity
- Trade Name
- Fiberglass Splint EUDAMED
- Device Name
- Fiberglass Splint EUDAMED
- Model / Reference
- AX315（75mm×300mm） EUDAMEDa＋420（100mm×500mm） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970210232444 EUDAMED
- Basic UDI-DI
- 697021023AX0023B EUDAMED
- EMDN Code
- M03050202 SYNTHETIC 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
Fiberglass Splint by Shaanxi Ansen Medical Technology Development 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 | 697021023AX0023B | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000050669
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 74d6bb05-ac67-470e-b7f5-a353203b2af0 61 fields · synced Jun 19, 2026