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6" Individual first aid dressing bandage with a sticker on the package
EUDAMEDClass I (EU MDR)
Ref Opatrunek modułowy OLARES 6”Model FB6, FB8
Identity
- Trade Name
- 6" Individual first aid dressing bandage with a sticker on the package EUDAMED
- Device Name
- First Aid Dressing Bandage EUDAMED
- Model / Reference
- FB6, FB8 EUDAMEDOpatrunek modułowy OLARES 6” EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454753193 EUDAMED
- Basic UDI-DI
- 69514547300UW EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
6" Individual first aid dressing bandage with a sticker on the package by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED
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 | 69514547300UW | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 760fa381-b8ce-498a-9741-40a3c553842c 61 fields · synced Jun 18, 2026