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Vitreal S
EUDAMEDClass IIa (EU MDR)
Ref 10001160Model TF12-01-1JRef 10001052Ref 10001145
Identity
- Trade Name
- VITREAL S EUDAMED
- Device Name
- VITREAL S EUDAMED
- Model / Reference
- TF12-01-1J EUDAMED10001160 EUDAMED10001052 EUDAMED10001145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100011602X EUDAMEDD-100010522T EUDAMEDD-1000114533 EUDAMED
- Basic UDI-DI
- B-100011602X EUDAMEDB-100010522T EUDAMEDB-1000114533 EUDAMED
- EMDN Code
- Q02030201 OPHTHALMIC DYES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDPoland EUDAMEDBelgium EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Vitreal S by Fidia Farmaceutici S.p.A. — Class IIa — 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-100011602X | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (3)
- EUDAMED e9d73953-f96f-40ac-bcff-6a7468183fb9 61 fields · synced Jul 31, 2026
- EUDAMED afb9caa7-67aa-4142-8f97-909ea17bed5d 61 fields · synced May 17, 2026
- EUDAMED 72a9ceb0-53c8-42b2-b856-6d7302f7c255 61 fields · synced May 18, 2026