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Scar Sheet
EUDAMEDClass I (EU MDR)
Ref SM4010Model SM4010 SM4015 SM4020 SM4030 SM4050 SM2530Ref SM4020Ref SM4015 Ref SM4050
Identity
- Trade Name
- Scar Sheet EUDAMED
- Device Name
- Scar Sheet EUDAMED
- Model / Reference
- SM4010 SM4015 SM4020 SM4030 SM4050 SM2530 EUDAMEDSM4010 EUDAMEDSM4020 EUDAMEDSM4015 EUDAMEDSM4050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979919800114 EUDAMED06979919800138 EUDAMED06979919800121 EUDAMED06979919800152 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 (4)
- EUDAMED 5e4f3a87-cc82-4419-8a83-6b4a5ab9d5b0 61 fields · synced Oct 6, 2026
- EUDAMED 61b92775-adc8-4d57-9a54-ba59ea9874c3 61 fields · synced May 18, 2026
- EUDAMED 55ec6bad-0aa4-4480-940e-09c4daa94e96 61 fields · synced May 18, 2026
- EUDAMED c731fed4-2c62-4730-a06f-094e5c6f3fb6 61 fields · synced May 19, 2026