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Ophthalmic Ultrasound Scanner
EUDAMEDClass IIa (EU MDR)
Ref Marvel B-scan with UBMRef Marvel B-scan
Identity
- Device Name
- Ophthalmic Ultrasound Scanner EUDAMED
- Model / Reference
- Marvel B-scan with UBM EUDAMEDMarvel B-scan EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904343742097 EUDAMED08904343742073 EUDAMED
- Basic UDI-DI
- 89043437BSCANWITHUBM4F EUDAMED89043437BSCANPR 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 | 89043437BSCANWITHUBM4F | 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 (2)
- EUDAMED fa89901d-e46e-4289-a240-47b986a19dfc 61 fields · synced Oct 6, 2026
- EUDAMED 18cd75f3-42d9-4192-8b80-3999c39254d3 61 fields · synced May 18, 2026