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Splint in blue color, size:11x100cm, 1pc/plastic bag with sticker
EUDAMEDClass I (EU MDR)
Ref /
Identity
- Trade Name
- Splint in blue color, size:11x100cm, 1pc/plastic bag with sticker EUDAMED
- Device Name
- First Aid Splint Roll EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454798903 EUDAMED
- Basic UDI-DI
- 69514547325VE EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
For emergency situations, a splint in blue color, size:11x100cm, 1pc/plastic bag with sticker is used as a temporary measure to immobilize and support injured limbs. This device provides stability, comfort, and ease of use, making it an ideal solution for first aid scenarios.
Similar devices
Also classified as Hand/finger splint, reusable.
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- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
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- 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 (1)
- EUDAMED dfae5f9c-471f-4130-9e20-9c3bc1f04f68 61 fields · synced Aug 1, 2026