← Back to catalogue
Finger Splints
EUDAMEDClass I (EU MDR)
Ref FS009Model FSO01, FSO02, FSO03,FSO04,FSO05,FSO06, FSO07, FSO08, FSO09,FS010,FS011
Identity
- Device Name
- Finger Splints EUDAMED
- Model / Reference
- FSO01, FSO02, FSO03,FSO04,FSO05,FSO06, FSO07, FSO08, FSO09,FS010,FS011 EUDAMEDFS009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200102155 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.
- Elastic Bandage — Anji Xinyuan Medical Supplies Co.,Ltd. · Class I
- Plastalume — BROWNMED, INC. · Class I
- Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Ortocare Sports Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000034229
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 9b907577-4626-45db-94d8-e2d7462bd635 61 fields · synced Jun 18, 2026