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Microclear
EUDAMEDClass IIa (EU MDR)
Ref OCT PLUS+CRO MAXModel ACRO models (12) , AOCT models (24)
Identity
- Trade Name
- Microclear EUDAMED
- Device Name
- Ophthalmic Laser Diagnosis Device EUDAMED
- Model / Reference
- ACRO models (12) , AOCT models (24) EUDAMEDOCT PLUS+CRO MAX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970990160692 EUDAMED
- Basic UDI-DI
- 697099016OLDDPZ EUDAMED
- Direct Marketing DI
- 06970990160692 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Microclear by Suzhou Microclear Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697099016OLDDPZ | 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 17b86871-8082-4bb0-a8b7-928fffd754b7 61 fields · synced May 29, 2026