← Back to catalogue
Digital Retinal Camera CR-10
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref BT8-2172Model Digital Retinal Camera
by Canon Inc.
Identity
- Trade Name
- Digital Retinal Camera CR-10 EUDAMEDCANON INC. FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- CR-10 EUDAMED
- Model / Reference
- Digital Retinal Camera EUDAMEDBT8-2172 EUDAMEDCR-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04549292228489 EUDAMEDFDA UDI
- Basic UDI-DI
- 4549292rc01DK EUDAMED
- 510(k) Number
- K241049 FDA UDI
- FDA Product Code
- HKI FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Digital Retinal Camera CR-10 by Canon Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111612 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4549292rc01DK | Class I | 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 (3)
- EUDAMED bf91e69b-1f68-453a-a345-4a4337241912 61 fields · synced Jul 18, 2026
- FDA UDI aa8fd3ac-3a20-4b61-b097-e2c6eb6d1a79 33 fields · synced May 30, 2026
- FDA 510(k) K111612 1 fields · synced May 18, 2026