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Fiberglass Splint
EUDAMEDClass I (EU MDR)
Ref AX645（150mm×1150mm）Model AX315（75mm×300mm）Ref AX325（75mm×900mm）Ref a+410（100mm×300mm）Ref a+530（125mmx600mm）Ref AX420（100mm×500mm）Ref a＋645（150mm×1150mm）Ref AX535（125mm×750mm）Ref a+730（175mmx750mm）Ref AX425（100mm×750mm）Ref a＋415（100mm×400mm）Ref a＋315（75mm×300mm）Ref a+515（125mm×400mm）Ref AX545（125mm×1150mm）Ref a＋325（75mm×900mm）Ref a+735（175mm×1150mm）Ref AX430（100mm×600mm）Ref a＋545（125mm×1150mm）Ref AX5355（125mm×770mm）
Identity
- Trade Name
- Fiberglass Splint EUDAMED
- Device Name
- Fiberglass Splint EUDAMED
- Model / Reference
- AX315（75mm×300mm） EUDAMEDAX645（150mm×1150mm） EUDAMEDAX325（75mm×900mm） EUDAMEDa+410（100mm×300mm） EUDAMEDa+530（125mmx600mm） EUDAMEDAX420（100mm×500mm） EUDAMEDa＋645（150mm×1150mm） EUDAMEDAX535（125mm×750mm） EUDAMEDa+730（175mmx750mm） EUDAMEDAX425（100mm×750mm） EUDAMEDa＋415（100mm×400mm） EUDAMEDa＋315（75mm×300mm） EUDAMEDa+515（125mm×400mm） EUDAMEDAX545（125mm×1150mm） EUDAMEDa＋325（75mm×900mm） EUDAMEDa+735（175mm×1150mm） EUDAMEDAX430（100mm×600mm） EUDAMEDa＋545（125mm×1150mm） EUDAMEDAX5355（125mm×770mm） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970210232369 EUDAMED06970210232284 EUDAMED06970210232420 EUDAMED06970210232505 EUDAMED06970210232307 EUDAMED06970210232543 EUDAMED06970210232338 EUDAMED06970210232550 EUDAMED06970210232321 EUDAMED06970210232437 EUDAMED06970210232406 EUDAMED06970210232482 EUDAMED06970210232345 EUDAMED06970210232413 EUDAMED06970210232567 EUDAMED06970210232314 EUDAMED06970210232529 EUDAMED06970210232390 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 (18)
- EUDAMED 56ea751c-787b-424a-91a1-22cb92534064 61 fields · synced Aug 4, 2026
- EUDAMED 9063f325-ee6c-44f3-8679-06a616f16694 61 fields · synced May 11, 2026
- EUDAMED e1433def-1c06-4095-adb6-655dfbea7992 61 fields · synced May 11, 2026
- EUDAMED f44d689b-c840-4181-8ecf-89c4c7ccb15c 61 fields · synced May 11, 2026
- EUDAMED 172da14b-c428-4dd8-b410-dfdda268ae78 61 fields · synced May 11, 2026
- EUDAMED 17d5ee86-8f15-40de-bb79-02a36ea7afd2 61 fields · synced May 11, 2026
- EUDAMED a8624705-f5dc-45b0-93ab-d33e72f64b37 61 fields · synced May 16, 2026
- EUDAMED c8778f56-97ff-4903-b791-3a5230301c90 61 fields · synced May 16, 2026
- EUDAMED 9b4ab592-4e05-4e11-9b52-b5f3a6cad801 61 fields · synced May 16, 2026
- EUDAMED e9e7d8cf-5529-4b0a-b8b4-c4ab3571856e 61 fields · synced May 17, 2026
- EUDAMED 051a1125-9bf6-4e9b-8287-dddabc91af00 61 fields · synced May 17, 2026
- EUDAMED 89089d28-7526-4c3e-ad51-1b7c17a12fee 61 fields · synced May 17, 2026
- EUDAMED 38429b17-5cdd-486d-a2b6-a3549a56a9f2 61 fields · synced May 17, 2026
- EUDAMED 94e41546-c163-405c-bad4-0facadf955cc 61 fields · synced May 17, 2026
- EUDAMED b2b4aec0-b1ef-4279-9630-5ce80a6e786d 61 fields · synced May 18, 2026
- EUDAMED b8471c6d-ad6c-407b-b762-019859cbfac0 61 fields · synced May 18, 2026
- EUDAMED b9cf0ccf-3745-425e-a141-f3e087a9e0b9 61 fields · synced May 18, 2026
- EUDAMED 69edbc19-e9e3-4969-9215-cbfab0a3f779 61 fields · synced May 19, 2026