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TersoHyal Preservative Free
EUDAMEDClass IIb (EU MDR)
Ref 92TRH010BGMModel Soluzione Oftalmica ad azione osmotica
Identity
- Trade Name
- TersoHyal Preservative Free EUDAMED
- Model / Reference
- Soluzione Oftalmica ad azione osmotica EUDAMED92TRH010BGM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034125186617 EUDAMED
- Basic UDI-DI
- 803412518TF162Z8 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
Yes
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
TersoHyal Preservative Free by Drugs Minerals and Generics Italia S.r.l. — Class IIb — 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 | 803412518TF162Z8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Drugs Minerals and Generics Italia S.r.l.
- EUDAMED SRN
- IT-MF-000024945
Sources (1)
- EUDAMED e381c998-62fa-495b-a4aa-6897006c9b28 61 fields · synced Jun 18, 2026