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Truglow
EUDAMEDClass I (EU MDR)
Ref Legend Truglow FS1-With Reinventer Binocular & Camera
Identity
- Trade Name
- Truglow EUDAMED
- Device Name
- Visualization System for Ophthalmic Micro Surgery EUDAMED
- Model / Reference
- Legend Truglow FS1-With Reinventer Binocular & Camera EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904343742332 EUDAMED
- Basic UDI-DI
- 89043437VSOM/AAOMWP EUDAMED
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
Classification
- Device Class
- Class I 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
Truglow by Appasamy Associates Private Limited — Class I — 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 | 89043437VSOM/AAOMWP | Class I | Active |
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Manufacturer
- Manufacturer
- Appasamy Associates Private Limited
- EUDAMED SRN
- IN-MF-000012093
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 546c4c87-ac15-4749-b7fc-8bbf155b1cfe 61 fields · synced Jun 18, 2026