Identity
- Trade Name
- PHIL-CAST EUDAMED
- Device Name
- Orthopedic casting tape / splint EUDAMED
- Model / Reference
- MK-3705 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809230103756 EUDAMED
- Basic UDI-DI
- 880923010castUJ EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Phil-Cast by MIKA Medical Co. — 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 | 880923010castUJ | Class I | Active |
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Manufacturer
- Manufacturer
- MIKA Medical Co.
- EUDAMED SRN
- KR-MF-000019144
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED f46c2549-94ec-435d-a270-98bba2f24863 61 fields · synced Jun 17, 2026