← Back to catalogue
Splint
EUDAMEDClass I (EU MDR)
Ref AS-01Model PS-01, PM-01, BS-01(L,M,S), AS-01, AS-02, AS-03, AS-04, AS-05D, AS-05F, AS-05H, AS-05K,TS-01, TS-02, AM-01Ref PS-01Ref TS-01Ref AS-05FRef AS-05DRef AS-05HRef BS-01(L)
Identity
- Device Name
- Splint EUDAMED
- Model / Reference
- PS-01, PM-01, BS-01(L,M,S), AS-01, AS-02, AS-03, AS-04, AS-05D, AS-05F, AS-05H, AS-05K,TS-01, TS-02, AM-01 EUDAMEDAS-01 EUDAMEDPS-01 EUDAMEDTS-01 EUDAMEDAS-05F EUDAMEDAS-05D EUDAMEDAS-05H EUDAMEDBS-01(L) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974442059152 EUDAMED06974442059114 EUDAMED06974442059251 EUDAMED06974442059244 EUDAMED06974442059220 EUDAMED06974442059329 EUDAMED06974442059299 EUDAMED
- Basic UDI-DI
- 697444205SP001GG 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
Splint by Jiangsu Rixin Medical Equipment 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 | 697444205SP001GG | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Rixin Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008761
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (7)
- EUDAMED 8fa4b3d5-dcfb-4062-b4fe-d7a6e63479dc 61 fields · synced Jul 20, 2026
- EUDAMED a6496c16-ecde-4953-b8c0-4b89bca725ff 61 fields · synced May 17, 2026
- EUDAMED 302ce9e8-4810-43c6-b355-eeb1e7597ced 61 fields · synced May 17, 2026
- EUDAMED bb2ac838-aa04-49ac-a654-a4e34e5d3091 61 fields · synced May 17, 2026
- EUDAMED af111207-11ed-4384-aba3-d93cfeb1b489 61 fields · synced May 18, 2026
- EUDAMED ce5026d7-e6cd-4007-9f95-9409ddc97742 61 fields · synced May 18, 2026
- EUDAMED d8a8afde-8467-42f9-b0cb-f23a6156420d 61 fields · synced May 19, 2026