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Microclear
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CROModel CSLO、CRO、CRO Plus、CRO-01
Identity
- Trade Name
- Microclear EUDAMEDFDA UDI
- Generic Name
- External ocular measurement camera FDA UDI
- Device Name
- Confocal Retina Ophthalmoscope EUDAMED
- Model / Reference
- CSLO、CRO、CRO Plus、CRO-01 EUDAMEDCRO EUDAMEDVS-Plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970990160128 EUDAMEDFDA UDI
- Basic UDI-DI
- 697099016CROTW EUDAMED
- Direct Marketing DI
- 06970990160128 EUDAMED
- FDA Product Code
- HKO FDA UDI
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- External ocular measurement camera FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Microclear by Suzhou Microclear Medical Instruments Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697099016CROTW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 6b8cffa2-4624-417e-a641-9e0847e463d3 61 fields · synced Jul 20, 2026
- FDA UDI c5a37410-b927-4407-a385-8412dacfa102 32 fields · synced May 30, 2026