← Back to catalogue
IV-SPLINT Szyna unieruchamiająca
EUDAMEDClass I (EU MDR)
Ref 04002Ref 04004Ref 04003
Identity
- Device Name
- IV-SPLINT Szyna unieruchamiająca EUDAMED
- Model / Reference
- 04002 EUDAMED04004 EUDAMED04003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59037193064232 EUDAMED59037193064614 EUDAMED59037193064478 EUDAMED
- Basic UDI-DI
- 590371931001210039D 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
IV-SPLINT Szyna unieruchamiająca by Sinmed Spółka Z Ograniczoną Odpowiedzialnością — 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 | 590371931001210039D | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sinmed Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002789
Sources (3)
- EUDAMED 218243f3-4f39-4c17-b40a-43ebd5c8612a 61 fields · synced Jul 9, 2026
- EUDAMED b1ae18d6-1224-48c1-8e22-607025914147 61 fields · synced May 18, 2026
- EUDAMED ade79f0a-f0eb-47c3-8422-88a9562b12e8 61 fields · synced May 19, 2026