Identity
- Trade Name
- Elastic Strap 3 cm EUDAMED
- Device Name
- Bandage EUDAMED
- Model / Reference
- 0.1~50cm*0.01~50m EUDAMED4156810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03583787660973 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IN0000034N EUDAMED
- EMDN Code
- M030402030102 ELASTIC SUPPORT BANDAGES, ADHESIVE 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
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
Elastic Strap 3 cm 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 646dc8e6-de08-4f83-8fea-ab557b694b6d 61 fields · synced Oct 6, 2026