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Sinogel
EUDAMEDClass III (EU MDR)
Ref 8053689860184Ref 8053689860177Ref 8033638958100Ref 8053689860146Ref 8053689860153Ref 8033638956021
Identity
- Trade Name
- SINOGEL EUDAMED
- Device Name
- SODIUM HYALURONATE 2.4% and SODIUM CHONDROITIN 1.6% - VISCO-SUPPLETIVE JOINT DEVICE EUDAMED
- Model / Reference
- 8053689860184 EUDAMED8053689860177 EUDAMED8033638958100 EUDAMED8053689860146 EUDAMED8053689860153 EUDAMED8033638956021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053689860184 EUDAMED08053689860177 EUDAMED08033638958100 EUDAMED08053689860146 EUDAMED08053689860153 EUDAMED08033638956021 EUDAMED
- Basic UDI-DI
- 803363895IA0024T EUDAMED
- Direct Marketing DI
- 08053689860184 EUDAMED08053689860177 EUDAMED08033638958100 EUDAMED08053689860146 EUDAMED08053689860153 EUDAMED08033638956021 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMEDHungary EUDAMEDFrance EUDAMEDFinland EUDAMEDDenmark EUDAMEDItaly 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 (6)
- EUDAMED 797efa40-41b1-434b-b53b-5ae68f46ebdd 61 fields · synced Aug 4, 2026
- EUDAMED 57ad6edd-fbbe-48b1-971e-f7b0802cec4e 61 fields · synced May 16, 2026
- EUDAMED 8280ef2d-9102-4dfb-816b-01ff4ae5bc51 61 fields · synced May 17, 2026
- EUDAMED 139fdb38-8cc1-4a2d-90d0-f50580b48345 61 fields · synced May 17, 2026
- EUDAMED bcdfa350-9fb6-4b6b-a826-fb9d8bd0dcd9 61 fields · synced May 18, 2026
- EUDAMED e9c49c87-b2f0-4db3-83a3-c92cc9aece0f 61 fields · synced May 18, 2026