Identity
- Trade Name
- SINOGEL EUDAMED
- Device Name
- SODIUM HYALURONATE 2.4% and SODIUM CHONDROITIN 1.6% - VISCO-SUPPLETIVE JOINT DEVICE EUDAMED
- Model / Reference
- 8053689860160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053689860160 EUDAMED
- Basic UDI-DI
- 803363895IA0024T EUDAMED
- Direct Marketing DI
- 08053689860160 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Sinogel by IBSA Farmaceutici Italia Srl — Class III — 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 | 803363895IA0024T | Class III | Active |
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Manufacturer
- Manufacturer
- Ibsa Farmaceutici Italia Srl
- EUDAMED SRN
- IT-MF-000008111
Sources (1)
- EUDAMED 76d0db7d-d4a1-4375-9363-ec9b4708fe78 61 fields · synced Jun 18, 2026