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Hydrocolloid Dressings
EUDAMEDClass I (EU MDR)
Ref SM51LModel SM40L SM36L SM51L SM52L SM45L SM5010 SM5015 SM5020 SM5030 SM5050Ref SM5010Ref SM5020Ref SM5030Ref SM5050
Identity
- Trade Name
- Hydrocolloid Dressings EUDAMED
- Device Name
- Hydrocolloid Dressings EUDAMED
- Model / Reference
- SM40L SM36L SM51L SM52L SM45L SM5010 SM5015 SM5020 SM5030 SM5050 EUDAMEDSM51L EUDAMEDSM5010 EUDAMEDSM5020 EUDAMEDSM5030 EUDAMEDSM5050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979919800039 EUDAMED06979919800060 EUDAMED06979919800084 EUDAMED06979919800091 EUDAMED06979919800107 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 (5)
- EUDAMED 5bc0bd1c-fc55-415c-bf01-f517142c738f 61 fields · synced Oct 6, 2026
- EUDAMED 73eda1c1-ea39-4543-9bf6-47abec02ca4f 61 fields · synced May 17, 2026
- EUDAMED a297b0c5-7ccf-41ab-b68b-300be9381b41 61 fields · synced May 17, 2026
- EUDAMED 471622a6-b7ad-4af8-b9aa-60116aaab124 61 fields · synced May 18, 2026
- EUDAMED 62c4c497-933c-40ab-8ff0-42b6cb6075c0 61 fields · synced May 19, 2026