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Medical Silicone Gel Dressing
EUDAMEDClass I (EU MDR)
Ref 20gModel 5g、 8g、10g、15g、18g、20g、25g、30g、40g、45g、50g Ref 50gRef 40gRef 18gRef 25g
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 EUDAMED20g EUDAMED50g EUDAMED40g EUDAMED18g EUDAMED25g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936943499905 EUDAMED06936943400116 EUDAMED06936943499929 EUDAMED06936943400055 EUDAMED06936943498434 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 EUDAMEDSpain EUDAMEDAustria 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 (5)
- EUDAMED 575c99fd-8499-4c54-ae44-7c3eeca9be5d 61 fields · synced Oct 6, 2026
- EUDAMED 4af85c09-8a95-42c9-811c-0b8c216533c2 61 fields · synced May 16, 2026
- EUDAMED 2b6674dd-caea-46c3-baac-46552b6d33ab 61 fields · synced May 17, 2026
- EUDAMED 9ea0546b-5e81-4303-ba30-b0c40b6398d5 61 fields · synced May 17, 2026
- EUDAMED 27a7e32a-10ee-4d51-bdfe-bc0cb575a524 61 fields · synced May 18, 2026