Identity
- Trade Name
- VISION VIBE EUDAMED
- Device Name
- Soft Contact Lens EUDAMED
- Model / Reference
- MCK1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942873001439 EUDAMED
- Basic UDI-DI
- 69422750MCK1RF EUDAMEDB-06942873001439 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
Vision Vibe by Gansu Constar Technology Group Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69422750MCK1RF | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69422750MCK1RF | 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 5565d79b-42f0-4545-9a9c-9d345a3cf215 61 fields · synced Jul 29, 2026
- EUDAMED 051ebda1-6685-45bf-962b-bdbc00bd5264 61 fields · synced Jul 29, 2026