Identity
- Trade Name
- Appasamy EUDAMED
- Device Name
- Binocular Indirect Ophthalmoscope EUDAMED
- Model / Reference
- AAIO Wireless EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904343700639 EUDAMED
- Basic UDI-DI
- 89043437AAIOWIRELESSVZ EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Appasamy 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 | 89043437AAIOWIRELESSVZ | Class I | Active |
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Manufacturer
- Manufacturer
- Appasamy Associates Private Limited
- EUDAMED SRN
- IN-MF-000013148
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 1a9d45f4-1b57-4e67-affc-1acb2e56a593 61 fields · synced Jun 19, 2026