Identity
- Device Name
- Dry-Eye Detector EUDAMED
- Model / Reference
- D600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973047190062 EUDAMED
- Basic UDI-DI
- 697304719006J6 EUDAMED
- Direct Marketing DI
- 06973047190062 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Dry-Eye Detector by ZD Medical Inc. — 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 | 697304719006J6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ZD Medical Inc.
- EUDAMED SRN
- CN-MF-000033176
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 85c2a542-3c4b-4d98-9bb8-a2a8b5eb9588 61 fields · synced Jul 9, 2026