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Orthopedic Cast
EUDAMEDClass I (EU MDR)
Ref Fiberglass/Polyester Cast 2in(5cm×360cm)Model Fiberglass/Polyester Cast ： 2in(5cm×360cm), 3in(7.5cm×360cm), 4in (10cm×360cm), 5in(12.5cm×360cm), 6in(15cm×360cm) ; 2in(5cm×270cm), 3in(7.5cm×270cm), 4in (10cm×270cm), 5in(12.5cm×270cm), 6in(15cm×270cm) etc
Identity
- Device Name
- Orthopedic Cast EUDAMED
- Model / Reference
- Fiberglass/Polyester Cast ： 2in(5cm×360cm), 3in(7.5cm×360cm), 4in (10cm×360cm), 5in(12.5cm×360cm), 6in(15cm×360cm) ; 2in(5cm×270cm), 3in(7.5cm×270cm), 4in (10cm×270cm), 5in(12.5cm×270cm), 6in(15cm×270cm) etc EUDAMEDFiberglass/Polyester Cast 2in(5cm×360cm) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970384030013 EUDAMED
- Basic UDI-DI
- 697038403OC001AQ EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER 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
Orthopedic Cast by Hebei Feikesi 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 | 697038403OC001AQ | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Feikesi Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000049665
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED eae39a4e-7b63-48dc-9444-bc083d6deff4 61 fields · synced Jul 17, 2026