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Silicone Scar Sheet
EUDAMEDClass I (EU MDR)
Ref X large 20×20cmModel C section,Tummy Tuck,Augmaplexy,Acne/Face,Medium,Large,X largeRef Medium 10×10cmRef Tummy Tuck 60×8cm
Identity
- Trade Name
- Silicone Scar Sheet EUDAMED
- Device Name
- Silicone Scar Sheet EUDAMED
- Model / Reference
- C section,Tummy Tuck,Augmaplexy,Acne/Face,Medium,Large,X large EUDAMEDX large 20×20cm EUDAMEDMedium 10×10cm EUDAMEDTummy Tuck 60×8cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951641900300 EUDAMED06951641900287 EUDAMED06951641900249 EUDAMED
- Basic UDI-DI
- 69516419P106PR EUDAMED
- Direct Marketing DI
- 06951641900300 EUDAMED06951641900287 EUDAMED06951641900249 EUDAMED
- EMDN Code
- M04040702 SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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 Changsha Hairun 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 | 69516419P106PR | Class I | Active |
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Manufacturer
- Manufacturer
- Changsha Hairun Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018236
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (3)
- EUDAMED 38f48235-ea64-4e6d-8e9c-4bec707d1930 61 fields · synced Jul 29, 2026
- EUDAMED 9fee79c3-141f-4573-bbc8-ff90d8e039aa 61 fields · synced May 18, 2026
- EUDAMED b7740d66-b031-4234-8440-280bb366ed2b 61 fields · synced May 18, 2026