Identity
- Trade Name
- Uni®20 Glaucoma Implant EUDAMED
- Device Name
- Uni®20 Glaucoma Implant EUDAMED
- Model / Reference
- P2020002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885018950019 EUDAMED
- Basic UDI-DI
- B-08885018950019 EUDAMED
- EMDN Code
- Q0208 GLAUCOMA DRAINAGES AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Uni®20 Glaucoma Implant by Advanced Ophthalmic Innovations Pte. Ltd. — 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-08885018950019 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Advanced Ophthalmic Innovations Pte. Ltd.
- EUDAMED SRN
- SG-MF-000008315
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 823b0a1c-64f1-4c13-8a02-e9c5cf11bb30 61 fields · synced Jul 18, 2026