Identity
- Device Name
- Ophthalmic Ultrasound Scanner EUDAMED
- Model / Reference
- Marvel II AB-scan EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904343742080 EUDAMED
- Basic UDI-DI
- 89043437ABSCANKT EUDAMED
- EMDN Code
- Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ophthalmic Ultrasound Scanner by Appasamy Associates Private Limited — Class IIa — 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 | 89043437ABSCANKT | Class IIa | 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 0f3870f1-69ef-4118-b030-8a4fa0167fac 61 fields · synced Jun 20, 2026