Identity
- Trade Name
- Microclear EUDAMED
- Device Name
- Confocal Retina Ophthalmoscope EUDAMED
- Model / Reference
- CRO-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06970990160180UM EUDAMED
- Basic UDI-DI
- B-06970990160180UM EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Microclear by Suzhou Microclear Medical Instruments 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-06970990160180UM | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970990160180UM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Microclear Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000014411
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED f0644785-60c5-407a-abf8-21fc3256b2dc 61 fields · synced May 29, 2026