Identity
- Trade Name
- 4business Adhesive bandage 10x6cm EUDAMED
- Device Name
- Plaster（nonwoven fabric) EUDAMED
- Model / Reference
- 45891 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820921126 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IN0000735B EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
4business Adhesive bandage 10x6cm 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 | 69228209MDN1204IN0000735B | 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 20f4b376-cc1b-4247-8b93-960fc0b4abea 61 fields · synced Jul 21, 2026