Identity
- Trade Name
- Mystic eyes EUDAMED
- Device Name
- Soft Contact Lens EUDAMED
- Model / Reference
- MC55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942873001613 EUDAMED
- Basic UDI-DI
- B-06942873001613 EUDAMED69422750MC55PQ EUDAMED
- EMDN Code
- Q021004010101 CONTACT LENSES - HYDROGEL, DAILY SINGLE-USE 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
Mystic eyes 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-06942873001613 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06942873001613 | 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 efafc02d-7075-415b-858e-0a584acb55d7 61 fields · synced Jul 21, 2026
- EUDAMED 4d372242-3b5d-4c67-8d54-15fc986764f2 61 fields · synced Jul 21, 2026