Identity
- Trade Name
- Wound Packing Gauze EUDAMED
- Device Name
- Sterile Bandage EUDAMED
- Model / Reference
- HFEB01 EUDAMEDHFEB01-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971519617413 EUDAMED
- Basic UDI-DI
- 697151961HFEB01EU 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
Category: Cast/bandage waterproof bathing cover, reusable
Wound Packing Gauze by Anji Hengfeng Sanitary Material Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 581a570b-a221-405b-9ee1-ea13ab3009e0 61 fields · synced Jul 9, 2026