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Orthopedic Splint
EUDAMEDClass I (EU MDR)
Ref N/AModel 5cm*25cm 7.5cm*30cm 7.5cm*75cm 7.5cm*90cm 10cm*40cm 10cm*45cm 10cm*50cm 10cm*65cm 10cm*75cm 12.5cm*50cm 12.5cm*65cm 12.5cm*75cm 12.5cm*90cm 12.5cm*115cm 12.5cm*120cm 15cm*75cm 15cm*115cm
Identity
- Device Name
- Orthopedic Splint EUDAMED
- Model / Reference
- 5cm*25cm 7.5cm*30cm 7.5cm*75cm 7.5cm*90cm 10cm*40cm 10cm*45cm 10cm*50cm 10cm*65cm 10cm*75cm 12.5cm*50cm 12.5cm*65cm 12.5cm*75cm 12.5cm*90cm 12.5cm*115cm 12.5cm*120cm 15cm*75cm 15cm*115cm EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976138431068 EUDAMED
- Basic UDI-DI
- 697613843OS01NR EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS 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
Category: Cotton wool roll, sterile
Orthopedic Splint by Hebei Youqi Medical Instrument Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697613843OS01NR | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Youqi Medical Instrument Ltd.
- EUDAMED SRN
- CN-MF-000033746
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2cf3dda0-2698-4d92-9b6e-4393c6e6ab16 61 fields · synced Jun 18, 2026