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Microclear
EUDAMEDClass IIa (EU MDR)
Ref OCT PLUS-3+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-3+CRO MAX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970990160814 EUDAMED
- Basic UDI-DI
- 697099016OLDDPZ EUDAMED
- Direct Marketing DI
- 06970990160814 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 is an advanced ophthalmic laser diagnosis device designed for well-informed professionals and patients. This Class IIa medical device features a high-resolution OCT Plus-3+CRO MAX imaging system, allowing for precise examination of the human eye.
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 21f36720-3784-4fa1-89f2-a0d70f80f1f0 61 fields · synced Jul 24, 2026