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Orthopedic Cast
EUDAMEDClass I (EU MDR)
Ref N/AModel 5cm*360cm 7.5cm*360cm 10cm*360cm 12.5cm*360cm 15cm*360cm 17.5cm*360cm 20cm*360cm
Identity
- Device Name
- Orthopedic Cast EUDAMED
- Model / Reference
- 5cm*360cm 7.5cm*360cm 10cm*360cm 12.5cm*360cm 15cm*360cm 17.5cm*360cm 20cm*360cm EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976138430078 EUDAMED06976138430047 EUDAMED06976138430054 EUDAMED06976138430030 EUDAMED06976138430061 EUDAMED
- Basic UDI-DI
- 697613843OC01L9 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 Cast 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 | 697613843OC01L9 | 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 (5)
- EUDAMED c8c935d4-9491-47be-9383-1dfe0d83f2dc 61 fields · synced Aug 3, 2026
- EUDAMED 7ca3f975-c88e-461b-a5d5-bf6cd5d29da5 61 fields · synced May 16, 2026
- EUDAMED 687dfaeb-b11b-42f9-acf3-e6b50ea591c2 61 fields · synced May 17, 2026
- EUDAMED e8af771c-dd01-464e-b5f3-453d66e7d427 61 fields · synced May 19, 2026
- EUDAMED 87c1eb14-2aaa-4162-b7ee-6e95bf6e158e 61 fields · synced May 19, 2026