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Orthopedic Splint
EUDAMEDClass I (EU MDR)
Ref Fiberglass/ Polyester Splint 312（7.5cm×30cm）Model Fiberglass/ Polyester Splint : 312（7.5cm×30cm），330(7.5cm×75cm), 335(7.5cm×90cm), 415(10cm×40cm) ，418(10cm×45cm）, 420(10cm×50cm) 430(10cm×75cm) ，520(12.5cm×50cm) , 525(12.5cm×65cm)，530(12.5cm×75cm), 545(12.5cm×115cm) etc
Identity
- Device Name
- Orthopedic Splint EUDAMED
- Model / Reference
- Fiberglass/ Polyester Splint : 312（7.5cm×30cm），330(7.5cm×75cm), 335(7.5cm×90cm), 415(10cm×40cm) ，418(10cm×45cm）, 420(10cm×50cm) 430(10cm×75cm) ，520(12.5cm×50cm) , 525(12.5cm×65cm)，530(12.5cm×75cm), 545(12.5cm×115cm) etc EUDAMEDFiberglass/ Polyester Splint 312（7.5cm×30cm） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970384030167 EUDAMED
- Basic UDI-DI
- 697038403OS001E8 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
Category: Hand/finger splint, reusable
Orthopedic Splint by Hebei Feikesi Medical Equipment Co., 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 | 697038403OS001E8 | 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 ec1bcd46-dff7-4c06-9138-2852b1b1456e 61 fields · synced Jun 17, 2026