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Medical polymer splint
EUDAMEDClass I (EU MDR)
Ref 430；10cm×75cmModel 312；7.5cm×30cm
Identity
- Trade Name
- Medical polymer splint EUDAMED
- Device Name
- Medical polymer splint EUDAMED
- Model / Reference
- 312；7.5cm×30cm EUDAMED430；10cm×75cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971642800065 EUDAMED
- Basic UDI-DI
- 697164280MPSM03050202BD EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Norway 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
Medical polymer splint by Shandong Haidike Medical Products 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 | 697164280MPSM03050202BD | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Haidike Medical Products Co Ltd
- EUDAMED SRN
- CN-MF-000026113
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 13ab91ec-fdcf-4bf2-91b8-a60ecb20313d 61 fields · synced Jul 23, 2026