Identity
- Trade Name
- Band Cohesive EUDAMED
- Device Name
- Bandage EUDAMEDCohesive bandage EUDAMED
- Model / Reference
- 0.1~50cm*0.01~50m EUDAMED4156902 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03583787660997 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IN0000034N EUDAMED69228209MDN1214IN00005668 EUDAMED
- EMDN Code
- M030402030102 ELASTIC SUPPORT BANDAGES, ADHESIVE EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMEDM030402020101 ELASTIC SUPPORT BANDAGES, COHESIVE, EXTENSIBLE IN ONE DIRECTION, 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
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
Band Cohesive 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 (2)
- EUDAMED 2eded6aa-4586-4fec-a0a2-4d0dbd54c933 61 fields · synced Jul 31, 2026
- EUDAMED c4055c10-0fa5-414a-b0ef-0bf43b60ef5f 61 fields · synced Jul 31, 2026