Identity
- Trade Name
- KSD EUDAMEDUYAAI EUDAMED
- Device Name
- Soft Contact Lens EUDAMED
- Model / Reference
- MCS1 EUDAMEDMC55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942671501810 EUDAMED
- Basic UDI-DI
- 69422750MCS1S7 EUDAMEDB-06942671501810 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
Ksd 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 | 69422750MCS1S7 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69422750MCS1S7 | 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 (3)
- EUDAMED 41e3f171-3f20-4810-93f6-c57167d0737b 61 fields · synced Jul 20, 2026
- EUDAMED 47f4068b-8f5d-4e93-8f05-1a3d7d8e47ff 61 fields · synced Jun 19, 2026
- EUDAMED a98a6e18-24a7-467b-988c-50f66aecc840 61 fields · synced Jul 20, 2026