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Optical Coherence Tomography OCT-R1
EUDAMEDClass IIa (EU MDR)
Ref BT8-2171Model Optical Coherence Tomography
by Canon Inc.
Identity
- Trade Name
- Optical Coherence Tomography OCT-R1 EUDAMED
- Device Name
- OCT-R1 EUDAMED
- Model / Reference
- Optical Coherence Tomography EUDAMEDBT8-2171 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04549292228540 EUDAMED
- Basic UDI-DI
- 4549292oc01CW EUDAMED
- EMDN Code
- Z12120113 OPHTHALMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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-R1 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 |
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Manufacturer
- Manufacturer
- Canon Inc.
- EUDAMED SRN
- JP-MF-000013254
- Authorised Representative
- Canon Medical Systems Europe B.V. NL-AR-000010531
Sources (1)
- EUDAMED 6ac6307a-b455-4fdc-a215-f2ec0bcfeed0 61 fields · synced Jul 14, 2026