← Back to catalogue
Optical Coherence Tomographer
EUDAMEDClass IIa (EU MDR)
Ref 507CP1001C8Model Mocean 3000Plus
Identity
- Device Name
- Optical Coherence Tomographer EUDAMED
- Model / Reference
- Mocean 3000Plus EUDAMED507CP1001C8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972039970026 EUDAMED
- Basic UDI-DI
- B-06972039970026 EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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-06972039970026 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen CERTAINN Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016915
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6d02c5f1-4bec-412b-8fbc-61e1b82cf375 61 fields · synced Jun 19, 2026