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Hydrocolloid Dressings
EUDAMEDClass I (EU MDR)
Ref SM40LModel SM40L SM36L SM51L SM52L SM45L SM5010 SM5015 SM5020 SM5030 SM5050
Identity
- Trade Name
- Hydrocolloid Dressings EUDAMED
- Device Name
- Hydrocolloid Dressings EUDAMED
- Model / Reference
- SM40L SM36L SM51L SM52L SM45L SM5010 SM5015 SM5020 SM5030 SM5050 EUDAMEDSM40L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979919800015 EUDAMED
- Basic UDI-DI
- 697991980HCDZK EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID 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
Hydrocolloid Dressings 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 | 697991980HCDZK | 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 127a344c-a5f7-4a2b-86db-8a3e9ef3a154 61 fields · synced Jun 18, 2026