← Back to catalogue
Optical Coherence Tomography OCT-S1
EUDAMEDClass IIa (EU MDR)
Ref BT8-2547Model Optical Coherence Tomography
by Canon Inc.
Identity
- Trade Name
- Optical Coherence Tomography OCT-S1 EUDAMED
- Device Name
- OCT-R1 EUDAMED
- Model / Reference
- Optical Coherence Tomography EUDAMEDBT8-2547 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04549292160451 EUDAMED
- Basic UDI-DI
- 4549292oc01CW EUDAMED
- EMDN Code
- Z12120113 OPHTHALMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern 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
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optical Coherence Tomography OCT-S1 by Canon Inc. — 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 | 4549292oc01CW | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Canon Inc.
- EUDAMED SRN
- JP-MF-000013254
- Authorised Representative
- Canon Medical Systems Europe B.V. NL-AR-000010531
Sources (1)
- EUDAMED e8f9a205-de35-45df-8d22-cc594a0861c6 61 fields · synced Jul 14, 2026