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corn foam cushion
EUDAMEDClass I (EU MDR)
Ref FA200-563746Model (2-12)cm x(2cm~2m) and so on
Identity
- Trade Name
- corn foam cushion EUDAMED
- Device Name
- Foot care cushion EUDAMED
- Model / Reference
- (2-12)cm x(2cm~2m) and so on EUDAMEDFA200-563746 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05706636563746 EUDAMED
- Basic UDI-DI
- 69228209MDN1214IN0000245T EUDAMED
- EMDN Code
- M03030299 PROTECTION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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: Cast/bandage waterproof bathing cover, reusable
corn foam cushion by RFX+CARE Manufacturing 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 | 69228209MDN1214IN0000245T | Class I | Active |
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Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED bfc41169-5568-456d-8921-035e146efdbb 61 fields · synced Jun 18, 2026