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Sterile Dressing Extra Large No 3
EUDAMEDClass I (EU MDR)
Ref 12403Model FB6, FB8
Identity
- Trade Name
- STERILE DRESSING EXTRA LARGE NO 3 EUDAMED
- Device Name
- First Aid Dressing Bandage EUDAMED
- Model / Reference
- FB6, FB8 EUDAMED12403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454760122 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
- 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Sterile Dressing Extra Large No 3 by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 | 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 7f0eebde-e1d0-4823-a67c-221c476c607b 61 fields · synced Oct 8, 2026