Identity
- Trade Name
- Traumafix Combat Dressing - Large EUDAMED
- Device Name
- Non-adherent absorbent dressings EUDAMED
- Model / Reference
- 10099 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060885040992 EUDAMED
- Basic UDI-DI
- 506013188CE02XF EUDAMED
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Traumafix Combat Dressing - Large by Reliance Medical (Shanghai) Limited — 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 | 506013188CE02XF | Class I | Active |
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Manufacturer
- Manufacturer
- Reliance Medical (Shanghai) Limited
- EUDAMED SRN
- CN-MF-000007382
- Authorised Representative
- Reliance Medical (Ireland) IE-AR-000003675
Sources (1)
- EUDAMED 201669cb-b6f5-40e8-a919-c227686b839c 61 fields · synced Jul 17, 2026