Identity
- Trade Name
- AKR 550 EUDAMED
- Device Name
- AKR 550 EUDAMED
- Model / Reference
- AKR550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615020000014 EUDAMED
- Basic UDI-DI
- 361502000000IAKR5500000WW EUDAMED
- EMDN Code
- Z12120113 OPHTHALMOMETERS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Akr 550 by Essilor International — 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 | 361502000000IAKR5500000WW | Class I | Active |
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Manufacturer
- Manufacturer
- Essilor International
- EUDAMED SRN
- FR-MF-000007175
Sources (2)
- EUDAMED 78a36c9d-bdca-4276-a41c-13b7e087b471 61 fields · synced Jun 17, 2026
- EUDAMED a82edd6f-0577-4a1f-9da2-a595a5f5f982 61 fields · synced Jun 11, 2026