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Splint
EUDAMEDClass I (EU MDR)
Ref JB001Model JB001 JB002 JB003 JB004 JB005 JB006 JB007 JB008 JB009 JB0010 JB0011 JB0012 JB0013 JB0014 JB0031 JB0032 JB0033 JB0034 JB0035 JB0036 JB0037 JB0038 JB0039 JB0040 JB0041
Identity
- Device Name
- SPLINT EUDAMED
- Model / Reference
- JB001 JB002 JB003 JB004 JB005 JB006 JB007 JB008 JB009 JB0010 JB0011 JB0012 JB0013 JB0014 JB0031 JB0032 JB0033 JB0034 JB0035 JB0036 JB0037 JB0038 JB0039 JB0040 JB0041 EUDAMEDJB001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813030206 EUDAMED
- Basic UDI-DI
- 697581303SPL01NW EUDAMED
- EMDN Code
- Y060603,Y061203 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
Splint by Anping Jianxin Orthopedics Instrnments 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 | 697581303SPL01NW | Class I | Active |
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Manufacturer
- Manufacturer
- Anping Jianxin Orthopedics Instrnments Co, .Ltd
- EUDAMED SRN
- CN-MF-000028658
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 11958855-db45-4466-b704-9b8eab049789 61 fields · synced Jun 19, 2026