Identity
- Trade Name
- SUSI LENS EUDAMED
- Device Name
- Soft Contact Lens EUDAMED
- Model / Reference
- MC55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942873001668 EUDAMED
- Basic UDI-DI
- 69422750MC55PQ EUDAMEDB-06942873001668 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
Susi Lens 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 | 69422750MC55PQ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69422750MC55PQ | 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 7ad19d9d-6ad6-49c5-8cd9-211fa9480d48 61 fields · synced Jul 21, 2026
- EUDAMED d6e73fbc-7f0f-400a-adf5-6b901a86292f 61 fields · synced Jul 21, 2026