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Medical Silicone Gel Dressing
EUDAMEDClass I (EU MDR)
Ref 10gModel 5g、 8g、10g、15g、18g、20g、25g、30g、40g、45g、50g
Identity
- Trade Name
- Medical Silicone Gel Dressing EUDAMED
- Device Name
- Medical Silicone Gel Dressing EUDAMED
- Model / Reference
- 5g、 8g、10g、15g、18g、20g、25g、30g、40g、45g、50g EUDAMED10g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936943400031 EUDAMED
- Basic UDI-DI
- 69369434MSGD001YV EUDAMED
- EMDN Code
- M04040702 SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Medical Silicone Gel Dressing by Henan Huibo Medical 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 | 69369434MSGD001YV | Class I | Active |
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Manufacturer
- Manufacturer
- Henan Huibo Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000013580
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4526c26f-0442-4073-80b9-3627edaaf089 61 fields · synced Jun 19, 2026