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Flexible Waterproof Bandages
EUDAMEDClass I (EU MDR)
Ref polyurethane/19mm x 57mmModel polyurethane/16mm x 57mm, polyurethane/19mm x 57mm, polyurethane/19mm x72mm, polyurethane/25mm x 76mm, polyurethane/38mm x 38mm, polyurethane/51mm x 76mm, polyurethane/51mm x 102mm,polyethylene/19mm x72mm,polyethylene/25mm x 76mm
Identity
- Device Name
- Flexible Waterproof Bandages EUDAMED
- Model / Reference
- polyurethane/16mm x 57mm, polyurethane/19mm x 57mm, polyurethane/19mm x72mm, polyurethane/25mm x 76mm, polyurethane/38mm x 38mm, polyurethane/51mm x 76mm, polyurethane/51mm x 102mm,polyethylene/19mm x72mm,polyethylene/25mm x 76mm EUDAMEDpolyurethane/19mm x 57mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973161440012 EUDAMED
- Basic UDI-DI
- 697316144FWB01F3 EUDAMED
- EMDN Code
- M03030299 PROTECTION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Cast/bandage waterproof bathing cover, reusable
Flexible Waterproof Bandages by Hubei Decen Biotechnology 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 | 697316144FWB01F3 | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Decen Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000003013
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 042503fd-850f-448b-bec6-cdeb32804c62 61 fields · synced Jun 18, 2026