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Tersohyal
EUDAMEDClass IIb (EU MDR)
Ref 92TRH010PLModel Soluzione Oftalmica ad Azione OsmoticaRef 92TRH010TRRef 92TRH010BG
Identity
- Trade Name
- Tersohyal EUDAMED
- Model / Reference
- Soluzione Oftalmica ad Azione Osmotica EUDAMED92TRH010PL EUDAMED92TRH010TR EUDAMED92TRH010BG EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ITMF2494592TRH010PLH2 EUDAMEDD-ITMF2494592TRH010TRHS EUDAMEDD-ITMF2494592TRH010BGFE EUDAMED
- Basic UDI-DI
- B-ITMF2494592TRH010PLH2 EUDAMEDB-ITMF2494592TRH010TRHS EUDAMEDB-ITMF2494592TRH010BGFE EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMEDTürkiye EUDAMEDBulgaria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Tersohyal by Drugs Minerals and Generics Italia S.r.l. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-ITMF2494592TRH010PLH2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Drugs Minerals and Generics Italia S.r.l.
- EUDAMED SRN
- IT-MF-000024945
Sources (3)
- EUDAMED 0fb87cfa-6747-4c50-b449-04f8e0590127 61 fields · synced Oct 6, 2026
- EUDAMED d7bd953f-4348-483a-ba86-166ecb7f8319 61 fields · synced May 18, 2026
- EUDAMED 3810aded-483c-4c1c-a3b0-d3fe953042b3 61 fields · synced May 19, 2026