Identity
- Trade Name
- KSD EUDAMEDUYAAI EUDAMED
- Device Name
- Soft Contact Lens EUDAMED
- Model / Reference
- MCS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942671501827 EUDAMED
- Basic UDI-DI
- 69422750MCS1S7 EUDAMEDB-06942671501827 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 32b8b0d6-2ad1-4a7d-aa41-abb93e2dbdb9 61 fields · synced Jul 12, 2026
- EUDAMED 298cdd21-0326-4971-8e4b-a69553419949 61 fields · synced Jun 11, 2026
- EUDAMED 990c4026-78dd-4d1a-a15d-ee89b009186b 61 fields · synced Jul 12, 2026