Identity
- Trade Name
- EyeSuite Myopia EUDAMED
- Device Name
- EyeSuite Myopia EUDAMED
- Model / Reference
- 1023815 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640132987775 EUDAMED
- Basic UDI-DI
- B-07640132987775 EUDAMED
- EMDN Code
- Z12120102 COMPUTERISED OPTICAL BIOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EyeSuite Myopia by Haag-Streit AG — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07640132987775 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07640132987775 | Class I | 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 (1)
- EUDAMED 4fb26e1d-019a-409f-be6f-045caccb1525 61 fields · synced Jun 19, 2026