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Splint
EUDAMEDClass I (EU MDR)
Ref BS-01(S)Model 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
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 EUDAMEDBS-01(S) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974442059145 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
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Also classified as Hand/finger splint, reusable.
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- 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 |
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Manufacturer
- Manufacturer
- Jiangsu Rixin Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008761
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 40b79813-9f06-4a27-a0fb-e1a76dd56d4d 61 fields · synced Jun 18, 2026