Identity
- Device Name
- RetCam Envision EUDAMED
- Model / Reference
- RetCam Envision EUDAMED60-000090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315011931 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 |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (1)
- EUDAMED bfdfb0e5-ef22-4170-8af5-40285b12a52f 61 fields · synced May 23, 2026