Identity
- Trade Name
- SPLINT EUDAMEDSplint set in a 70D blue bag including 1pcs 11x100cm, 1pcs 11x50cm, 2pcs 11x5cm, bag size: 18x11.5x5.5cm EUDAMED
- Device Name
- First Aid Splint Roll EUDAMED
- Model / Reference
- REF 2301002 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454746089 EUDAMED06951454717935 EUDAMED
- Basic UDI-DI
- 69514547325VE EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDPoland 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: Hand/finger splint, reusable
Splint by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
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- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
- MedTextile — Medtex Swiss Ltd · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
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 | 69514547325VE | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED d9938364-fd82-453f-9c53-7f750288d967 61 fields · synced Jun 20, 2026
- EUDAMED 1f4d05c4-55fc-4eeb-b043-3c15357af915 61 fields · synced May 18, 2026