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Ophthalmic Green Laser System – 532nm
EUDAMEDClass IIb (EU MDR)
Ref Amogh Smart
Identity
- Device Name
- Ophthalmic Green Laser System – 532nm EUDAMED
- Model / Reference
- Amogh Smart EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904343700684 EUDAMED
- Basic UDI-DI
- 89043437AMOGHSMARTAS EUDAMED
- EMDN Code
- Z12120202 LASER PHOTOCOAGULATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
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
Ophthalmic Green Laser System – 532nm by Appasamy Associates Private Limited — 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 | 89043437AMOGHSMARTAS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Appasamy Associates Private Limited
- EUDAMED SRN
- IN-MF-000013149
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 3ed66d21-8d3a-486f-9d1a-fcd66fbdab9b 61 fields · synced Oct 6, 2026