Identity
- Trade Name
- Foam underwrap EUDAMED
- Device Name
- Bandage EUDAMED
- Model / Reference
- 0.1~50cm*0.01~50m EUDAMED4156831 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03583787660980 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IN0000034N EUDAMED
- EMDN Code
- M030402010103 ELASTIC SUPPORT BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS, HIGH EXTENSIBILITY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Foam underwrap by RFX+CARE Manufacturing 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 | 69228209MDN1204IN0000034N | 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 911113f1-46d9-4663-8fa6-e68d0d7eedcd 61 fields · synced Jun 19, 2026