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Splint
EUDAMEDClass I (EU MDR)
Ref TS-02Model 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 EUDAMEDTS-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974442059268 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
Splint by Jiangsu Rixin Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 dba8dc43-2109-4867-9076-62f3194b42e2 61 fields · synced Jun 18, 2026