Identity
- Trade Name
- GUM HYDRAL GEL EUDAMED
- Device Name
- GUM HYDRAL GEL EUDAMED
- Model / Reference
- 6000, 6002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17630019900734 EUDAMED
- Basic UDI-DI
- B-17630019900734 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Gum Hydral Gel by Sunstar Europe SA — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-17630019900734 | Class I | Active |
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Manufacturer
- Manufacturer
- Sunstar Europe SA
- EUDAMED SRN
- CH-MF-000023162
- Authorised Representative
- Sunstar France FR-AR-000018318
Sources (2)
- EUDAMED af5425cf-7048-416b-bfec-384b3f37c032 61 fields · synced Oct 6, 2026
- EUDAMED af5425cf-7048-416b-bfec-384b3f37c032-1 61 fields · synced Jun 10, 2026