← Back to catalogue
RetCam Envision
EUDAMEDClass I (EU MDR)
Ref 61-000300Model RetCam EnvisionRef 61-000400
Identity
- Device Name
- RetCam Envision EUDAMED
- Model / Reference
- RetCam Envision EUDAMED61-000300 EUDAMED61-000400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315011597 EUDAMED05713315011955 EUDAMED
- Basic UDI-DI
- 5713315NA0001453 EUDAMED
- EMDN Code
- Z12120105 FLUOROANGIOGRAPHS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
RetCam Envision by Natus Medical Denmark ApS — Class I — 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 | 5713315NA0001453 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED a329b8c5-4d3b-4e21-9cf6-9a0a637e33b1 61 fields · synced Jul 28, 2026
- EUDAMED 66a954c6-6123-453d-a2a3-b6a2b55e083f 61 fields · synced Jul 28, 2026