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Silicone Scar Sheet
EUDAMEDClass I (EU MDR)
Ref Augmaplexy 8×15cmModel C section,Tummy Tuck,Augmaplexy,Acne/Face,Medium,Large,X large
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 EUDAMEDAugmaplexy 8×15cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951641900263 EUDAMED
- Basic UDI-DI
- 69516419P106PR EUDAMED
- Direct Marketing DI
- 06951641900263 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 (1)
- EUDAMED be24a966-1fc2-4664-9fe2-da03df6df11d 61 fields · synced Jun 19, 2026