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Finger Splints
EUDAMEDClass I (EU MDR)
Ref FS002Model FSO01, FSO02, FSO03,FSO04,FSO05,FSO06, FSO07, FSO08, FSO09,FS010,FS011Ref FS004Ref FS001Ref FS007Ref FSO01Ref FS008Ref FS011Ref FS005
Identity
- Device Name
- Finger Splints EUDAMED
- Model / Reference
- FSO01, FSO02, FSO03,FSO04,FSO05,FSO06, FSO07, FSO08, FSO09,FS010,FS011 EUDAMEDFS002 EUDAMEDFS004 EUDAMEDFS001 EUDAMEDFS007 EUDAMEDFSO01 EUDAMEDFS008 EUDAMEDFS011 EUDAMEDFS005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200102087 EUDAMED06976200102100 EUDAMED06976200102070 EUDAMED06976200102131 EUDAMED06976200100113 EUDAMED06976200102148 EUDAMED06976200102179 EUDAMED06976200102117 EUDAMED
- Basic UDI-DI
- 697620010FS00178 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Finger Splints by Xiamen Ortocare Sports Health 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 | 697620010FS00178 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Ortocare Sports Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000034229
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (8)
- EUDAMED b729cfa3-e281-4f09-a191-b0d758ca9f62 61 fields · synced Jul 31, 2026
- EUDAMED e60e5b14-21c9-4217-be13-2a885f587a0e 61 fields · synced May 17, 2026
- EUDAMED c9eed7a1-42d3-4ebb-bd2d-31fb15ffbb5f 61 fields · synced May 17, 2026
- EUDAMED 24595bfd-b4b6-48fc-975f-7a53d3b03bae 61 fields · synced May 17, 2026
- EUDAMED 8850488d-6fa9-41e8-91a2-67f786221f58 61 fields · synced May 17, 2026
- EUDAMED c6a355ae-1853-4746-b1da-ad5783376ae1 61 fields · synced May 17, 2026
- EUDAMED b8b55cd9-7abb-4333-9074-195cf36d704c 61 fields · synced May 18, 2026
- EUDAMED e0bd4d09-7355-43ae-b235-502a7e3443a6 61 fields · synced May 18, 2026