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Microclear
EUDAMEDClass IIa (EU MDR)
Ref OCT-2+CRO SEModel ACRO models (12) , AOCT models (24)Ref CRO PRO-2Ref OCT-3Ref OCT-3+CRO SERef OCT PLUS-2+CRO SERef HFCRef OCT-2Ref VS-ProRef OCT PLUS-3+CRO PRORef OCT-3+CRO PRORef OCT-2+CRO PRORef VS-PlusModel VS、VS-Pro、VS-PlusRef CRO SE-6Ref CRO MAXRef OCT PLUS+CRO SERef CRO SERef CRO SE-4Ref CRO SE-5Ref OCT PLUS-3+CRO SERef CRO PlusModel CSLO、CRO、CRO Plus、CRO-01Ref CRO-01Ref VS
Identity
- Trade Name
- Microclear EUDAMED
- Device Name
- Ophthalmic Laser Diagnosis Device EUDAMEDHand-held Fundus Camera EUDAMEDVision Screener EUDAMEDConfocal Retina Ophthalmoscope EUDAMED
- Model / Reference
- ACRO models (12) , AOCT models (24) EUDAMEDOCT-2+CRO SE EUDAMEDCRO PRO-2 EUDAMEDOCT-3 EUDAMEDOCT-3+CRO SE EUDAMEDOCT PLUS-2+CRO SE EUDAMEDHFC EUDAMEDOCT-2 EUDAMEDVS-Pro EUDAMEDOCT PLUS-3+CRO PRO EUDAMEDOCT-3+CRO PRO EUDAMEDOCT-2+CRO PRO EUDAMEDVS、VS-Pro、VS-Plus EUDAMEDVS-Plus EUDAMEDCRO SE-6 EUDAMEDCRO MAX EUDAMEDOCT PLUS+CRO SE EUDAMEDCRO SE EUDAMEDCRO SE-4 EUDAMEDCRO SE-5 EUDAMEDOCT PLUS-3+CRO SE EUDAMEDCSLO、CRO、CRO Plus、CRO-01 EUDAMEDCRO Plus EUDAMEDCRO-01 EUDAMEDVS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970990160920 EUDAMED06970990160975 EUDAMED06970990160951 EUDAMED06970990160937 EUDAMED06970990160845 EUDAMEDD-06970990160012TX EUDAMED06970990160944 EUDAMEDD-06970990160111U2 EUDAMED06970990160838 EUDAMED06970990160913 EUDAMED06970990160906 EUDAMED06970990160227 EUDAMED06970990161040 EUDAMED06970990160777 EUDAMED06970990160715 EUDAMED06970990160791 EUDAMED06970990161026 EUDAMED06970990161033 EUDAMED06970990160852 EUDAMED06970990160203 EUDAMED06970990160180 EUDAMED06970990160005 EUDAMEDD-06970990160128UK EUDAMED
- Basic UDI-DI
- 697099016OLDDPZ EUDAMEDB-06970990160012TX EUDAMEDB-06970990160111U2 EUDAMED697099016VSPX2 EUDAMED697099016CROTW EUDAMEDB-06970990160128UK EUDAMED
- Direct Marketing DI
- 06970990160920 EUDAMED06970990160975 EUDAMED06970990160951 EUDAMED06970990160937 EUDAMED06970990160845 EUDAMED06970990160944 EUDAMED06970990160838 EUDAMED06970990160913 EUDAMED06970990160906 EUDAMED06970990160227 EUDAMED06970990161040 EUDAMED06970990160777 EUDAMED06970990160715 EUDAMED06970990160791 EUDAMED06970990161026 EUDAMED06970990161033 EUDAMED06970990160852 EUDAMED06970990160203 EUDAMED06970990160180 EUDAMED06970990160005 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands EUDAMEDNorthern Ireland 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Microclear by Suzhou Microclear Medical Instruments Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697099016OLDDPZ | Class IIa | Active |
| 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 (23)
- EUDAMED 7fa8e60f-d451-46fe-8b78-5a4b1eb73be0 61 fields · synced Sep 18, 2026
- EUDAMED e50a9b93-d949-4bb1-8207-f4dd30447bd2 61 fields · synced May 16, 2026
- EUDAMED 286a3296-d932-44f2-ad71-e42a3ce5901d 61 fields · synced May 16, 2026
- EUDAMED b54fdb17-e059-406f-a719-75e5877ea484 61 fields · synced May 16, 2026
- EUDAMED 95c42703-d027-45ca-94e3-0364f962b2b6 61 fields · synced May 16, 2026
- EUDAMED be074ce0-9c8b-431b-bf53-3c991de1be68 61 fields · synced May 16, 2026
- EUDAMED bf6574eb-1fd1-47c6-83a2-0ea066955386 61 fields · synced May 17, 2026
- EUDAMED 2b6ba6fd-f962-4fea-8b07-83a0019f62c7 61 fields · synced May 17, 2026
- EUDAMED 146f76e6-f9cb-4704-a0b6-16d876a6671c 61 fields · synced May 17, 2026
- EUDAMED 71f83957-b30d-4c18-a34e-7ddd8149e634 61 fields · synced May 17, 2026
- EUDAMED 958aac9b-419e-4436-aa9d-4937c8d7771b 61 fields · synced May 17, 2026
- EUDAMED a8308611-d2ba-4e2b-95b0-069443f6d95a 61 fields · synced May 17, 2026
- EUDAMED b8efe4a1-e585-44de-a95a-16ccf523c36c 61 fields · synced May 18, 2026
- EUDAMED ca608da6-11e3-4f01-86bf-513bc45c0123 61 fields · synced May 18, 2026
- EUDAMED acc66879-f282-4197-95b2-60a8990a09b2 61 fields · synced May 18, 2026
- EUDAMED 8fca26bc-ecd9-448f-b805-3a38b77a6071 61 fields · synced May 18, 2026
- EUDAMED bf9da1d2-9b9a-4d70-8241-6a704fa3b3e5 61 fields · synced May 18, 2026
- EUDAMED 9240ed9f-6b5b-48fe-bea0-7f1d8398cc32 61 fields · synced May 18, 2026
- EUDAMED 1dd36c77-17b5-44f2-874f-8eb8e14db8a4 61 fields · synced May 19, 2026
- EUDAMED 181a5f14-a60f-4f79-8a4d-aeba7a7afa30 61 fields · synced May 19, 2026
- EUDAMED 5a2eba72-52de-47fd-9a59-e43870c279fb 61 fields · synced May 19, 2026
- EUDAMED 3736f533-8e8f-4d24-a9eb-10391b5ba534 61 fields · synced May 19, 2026
- EUDAMED e52fe07f-a8f7-4021-be3e-88222978ea21 61 fields · synced May 19, 2026