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Truglow
EUDAMEDClass I (EU MDR)
Ref Legend Truglow FS-1Ref Legend Truglow FS1-With Integrated Assistancescope & Camera Ref Legend Truglow FS1 - Without Camera
Identity
- Trade Name
- Truglow EUDAMED
- Device Name
- Visualization System for Ophthalmic Micro Surgery EUDAMED
- Model / Reference
- Legend Truglow FS-1 EUDAMEDLegend Truglow FS1-With Integrated Assistancescope & Camera EUDAMEDLegend Truglow FS1 - Without Camera EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904343700547 EUDAMED08904343742349 EUDAMED08904343742325 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 (3)
- EUDAMED 9c5ec003-53b4-4613-9066-a5be954d051b 61 fields · synced Oct 6, 2026
- EUDAMED 6b073144-9554-444b-84c1-d6737b918bd2 61 fields · synced Jul 12, 2026
- EUDAMED 864aa38f-524d-462b-bb1f-73af587a5222 61 fields · synced Jul 31, 2026