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Silicone Scar Sheet
EUDAMEDClass I (EU MDR)
Ref 1.6in x 120 in(4cm x 3m)Model 1.6in x 40 in(4cm x 1.0m), 1.6in x 60 in(4cm x 1.5m), 1.6in x 120 in(4cm x 3m),customized size.
Identity
- Device Name
- Silicone Scar Sheet EUDAMED
- Model / Reference
- 1.6in x 40 in(4cm x 1.0m), 1.6in x 60 in(4cm x 1.5m), 1.6in x 120 in(4cm x 3m),customized size. EUDAMED1.6in x 120 in(4cm x 3m) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973161441200 EUDAMED
- Basic UDI-DI
- 697316144SSS01MB EUDAMED
- EMDN Code
- M03030199 ELASTIC FIXING BANDAGES - 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
Silicone Scar Sheet by Hubei Decen Biotechnology 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 | 697316144SSS01MB | 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 5e11c8ec-9774-481a-92f0-a2df90a121b0 61 fields · synced Jun 18, 2026