Identity
- Trade Name
- AYOONZ EUDAMED
- Device Name
- soft contact lens EUDAMED
- Model / Reference
- MCK1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942671500943 EUDAMED
- Basic UDI-DI
- B-06942671500943 EUDAMED69422750MCK1RF EUDAMED
- EMDN Code
- Q0210040102 CONTACT LENSES - HYDROGEL, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Ayoonz by Gansu Constar Technology Group Co., Ltd. — Class IIa — 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-06942671500943 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06942671500943 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gansu Constar Technology Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000041579
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (2)
- EUDAMED 7ca521b6-82f6-47a2-a25b-077d87097c34 61 fields · synced Sep 18, 2026
- EUDAMED 5d879208-832d-4376-b4ca-f502d04348a6 61 fields · synced Sep 18, 2026