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TraumaFix Compressed Gauze
EUDAMEDClass I (EU MDR)
Ref 04.REF.10047Model HFEB01
Identity
- Trade Name
- TraumaFix Compressed Gauze EUDAMED
- Device Name
- Sterile Bandage EUDAMED
- Model / Reference
- HFEB01 EUDAMED04.REF.10047 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971519613491 EUDAMED
- Basic UDI-DI
- 697151961HFEB01EU EUDAMED
- Direct Marketing DI
- 06971519613491 EUDAMED
- EMDN Code
- M03030299 PROTECTION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Compressed Gauze by Anji Hengfeng Sanitary Material 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 | 697151961HFEB01EU | Class I | Active |
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Manufacturer
- Manufacturer
- Anji Hengfeng Sanitary Material Co., Ltd
- EUDAMED SRN
- CN-MF-000013051
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 7104ec15-ff2e-43b7-ae2d-0f983a60ac9d 61 fields · synced Jun 20, 2026