Identity
- Trade Name
- EyeSuite Myopia EUDAMED
- Device Name
- EyeSuite Myopia EUDAMED
- Model / Reference
- 1023815 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640132988802 EUDAMED07640132988093 EUDAMED07640132987782 EUDAMED
- Basic UDI-DI
- 764013298MyopiaDJ EUDAMED
- Direct Marketing DI
- 07640132988802 EUDAMED07640132988093 EUDAMED07640132987782 EUDAMED
- EMDN Code
- Z12120102 COMPUTERISED OPTICAL BIOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
EyeSuite Myopia by Haag-Streit AG — 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 | 764013298MyopiaDJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Haag-Streit AG
- EUDAMED SRN
- CH-MF-000020981
- Authorised Representative
- Haag-Streit Deutschland GmbH DE-AR-000025462
Sources (3)
- EUDAMED 5c18eb47-d912-496c-abab-7b533b034de9 61 fields · synced Sep 18, 2026
- EUDAMED fe0c4ed1-6fee-4a6e-b5bc-1743111e3fa9 61 fields · synced May 16, 2026
- EUDAMED 4cd6a830-8641-4660-9f5a-5630d035630a 61 fields · synced May 19, 2026