Identity
- Trade Name
- HeltiQ Gauze compress, EUDAMED
- Device Name
- Gauze compress EUDAMED
- Model / Reference
- 5*8.5cm EUDAMED556403R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717484792438 EUDAMED
- Basic UDI-DI
- B-08717484792438 EUDAMED
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
HeltiQ Gauze compress, 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-08717484792438 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 2b4e9cc2-d110-4009-9641-4773d32f7401 61 fields · synced Jul 14, 2026