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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*115cmRef 5cm*25cm
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 EUDAMED5cm*25cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976138431136 EUDAMED06976138431112 EUDAMED06976138431129 EUDAMED06976138431174 EUDAMED06976138431105 EUDAMED06976138431013 EUDAMED06976138431082 EUDAMED06976138431143 EUDAMED06976138431020 EUDAMED06976138431051 EUDAMED06976138431075 EUDAMED06976138431167 EUDAMED06976138431099 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 (13)
- EUDAMED abac6f87-e66a-4fa6-9604-aea6fb62838c 61 fields · synced Aug 1, 2026
- EUDAMED f6494d6e-cd3b-44ff-9ac7-08b1a8d1b893 61 fields · synced May 17, 2026
- EUDAMED f992da7b-64e1-48d2-8688-d184b2eded98 61 fields · synced May 17, 2026
- EUDAMED 15ebd552-8cbb-4db6-b436-93a237790592 61 fields · synced May 17, 2026
- EUDAMED 11c6bc98-aa3a-4d23-9ca0-3f012fea1747 61 fields · synced May 18, 2026
- EUDAMED fdedb3d5-bdfb-4be4-aa26-c9909c273e85 61 fields · synced May 18, 2026
- EUDAMED f3e6f4c9-8fc8-4561-ae13-4c693647d924 61 fields · synced May 19, 2026
- EUDAMED 636a436e-5f51-4cb4-aa5d-6af233ae13e8 61 fields · synced May 19, 2026
- EUDAMED 60fbafac-1a3d-4adc-ac0e-f4ee2496e891 61 fields · synced May 19, 2026
- EUDAMED a7bdceb9-01ae-446b-b8e7-6f00dd19ced0 61 fields · synced May 19, 2026
- EUDAMED 4c131e56-cac6-4b83-99c5-f3a525e09dbb 61 fields · synced May 19, 2026
- EUDAMED 2d8fa864-1e20-4182-8f41-2e3598ec6052 61 fields · synced May 19, 2026
- EUDAMED 3d05ba55-27e8-4165-8c02-15b05f517d73 61 fields · synced May 19, 2026