Identity
- Trade Name
- Hetiq Woundplasterset textile EUDAMED
- Device Name
- plaster EUDAMED
- Model / Reference
- 10*6cm EUDAMED1200202R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717484792476 EUDAMED
- Basic UDI-DI
- B-08717484792476 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hetiq Woundplasterset textile by RFX+CARE Manufacturing Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08717484792476 | 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 cd2d2efc-4c2f-43a0-b875-3e1ab4b81a12 61 fields · synced Jun 18, 2026