Microclear
by Suzhou Microclear Medical Instruments Co., Ltd 40 variants
Ref CRO-01Model CSLO、CRO、CRO Plus、CRO-01
Microclear (CRO-01) is a medical device (EU MDR Class IIa; EMDN category ophtalmology assessments and diagnosis instruments – other) made by Suzhou Microclear Medical Instruments Co., Ltd., registered in EUDAMED on 3 Jan 2022 (Basic UDI-DI B-06970990160180UM) with CE/MDR certificate CN25/00003315 valid until 20 May 2030, active as of 24 Oct 2026.
Active
Valid until
20 May 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN25/00003315 | Date28 Jul 2026 | StatusActive |
| European Union | CE/MDD | NumberB-06970990160180UM | Date3 Jan 2022 | StatusActive |
Official records
- EUDAMED public site B-06970990160180UM
Certificates
- CN25/00003315 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 28 Jul 2026
- Expires
- 20 May 2030
- Reason
- Mnf data change
Timeline
- Registered EUDAMED B-06970990160180UM
- Certificate issued EUDAMED CN25/00003315
- Certificate expires EUDAMED CN25/00003315
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device name
- Confocal Retina Ophthalmoscope
- Model / reference
- CRO-01, CSLO、CRO、CRO Plus、CRO-01
- Primary DI / UDI-DI
- D-06970990160180UM, 06970990160180
- Basic UDI-DI
- B-06970990160180UM, 697099016CROTW
- Direct marketing DI
- 06970990160180
- EMDN code
- Z12120199 Ophtalmology assessments and diagnosis instruments – other
- Device class
- Class IIa
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- Northern IrelandGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014411
- Authorised representative
- Wellkang Ltd XI-AR-000001836
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