Identity
- Device Name
- Vyntus ONE EUDAMED
- Model / Reference
- V-178601 EUDAMEDV-178602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250892908786 EUDAMED04250892908793 EUDAMED
- Basic UDI-DI
- 42508929041512AHT EUDAMED
- Direct Marketing DI
- 04250892908786 EUDAMED04250892908793 EUDAMED
- EMDN Code
- Z12159099 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Vyntus ONE by Jaeger Medical GmbH — 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 | 42508929041512AHT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jaeger Medical GmbH
- EUDAMED SRN
- DE-MF-000007090
Sources (2)
- EUDAMED 9fb5c2e0-7b0b-4356-8b82-bac23f43ef4b 61 fields · synced Jul 23, 2026
- EUDAMED a3a538b4-06c8-4d39-a974-f92853f5fd54 61 fields · synced May 17, 2026