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Scar Sheet
EUDAMEDClass I (EU MDR)
Ref SM2530Model SM4010 SM4015 SM4020 SM4030 SM4050 SM2530
Identity
- Trade Name
- Scar Sheet EUDAMED
- Device Name
- Scar Sheet EUDAMED
- Model / Reference
- SM4010 SM4015 SM4020 SM4030 SM4050 SM2530 EUDAMEDSM2530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979919800169 EUDAMED
- Basic UDI-DI
- 697991980SRS5Q EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED 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
Scar Sheet by Dongguan Samvo 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 | 697991980SRS5Q | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Samvo Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000052566
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (1)
- EUDAMED f792c247-b132-4fee-99c3-29e44e8603a1 61 fields · synced Jun 17, 2026