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Fiberglass Splint
EUDAMEDClass I (EU MDR)
Ref a+520（125mm×500mm）Model AX315（75mm×300mm）
Identity
- Trade Name
- Fiberglass Splint EUDAMED
- Device Name
- Fiberglass Splint EUDAMED
- Model / Reference
- AX315（75mm×300mm） EUDAMEDa+520（125mm×500mm） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970210232499 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
Category: Cotton wool roll, sterile
Fiberglass Splint by Shaanxi Ansen Medical Technology Development Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 e453d62b-e4ca-4285-a94c-44a20100953e 61 fields · synced Jun 18, 2026