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Optical Coherence Tomographer
EUDAMEDClass IIa (EU MDR)
Ref 507CP0002/507CP1001/508CP0003/510CP0001Model Mocean 3000/Mocean 3000Plus/Mocean 4000 /OSE-2800Ref 510CP0001Model OSE-2800Ref 508CP0003Model Mocean 4000
Identity
- Device Name
- Optical Coherence Tomographer EUDAMED
- Model / Reference
- Mocean 3000/Mocean 3000Plus/Mocean 4000 /OSE-2800 EUDAMED507CP0002/507CP1001/508CP0003/510CP0001 EUDAMEDOSE-2800 EUDAMED510CP0001 EUDAMEDMocean 4000 EUDAMED508CP0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF000016915YKAA6V EUDAMED06972039970095 EUDAMED06972039970019 EUDAMED
- Basic UDI-DI
- B-CNMF000016915YKAA6V EUDAMEDB-06972039970095 EUDAMEDB-06972039970019 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMEDZ12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optical Coherence Tomographer by Shenzhen Certainn Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-CNMF000016915YKAA6V | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen CERTAINN Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016915
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 20341fc9-9c9d-4492-b8f2-f600c11900c1 61 fields · synced Jul 24, 2026
- EUDAMED 65823144-5823-42d5-a5fa-da0e5c2b64f2 61 fields · synced Jul 13, 2026
- EUDAMED 1eb60daa-f7a1-4e7e-bd00-ca889be68df5 61 fields · synced Jul 24, 2026