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Ventilator
EUDAMEDClass IIb (EU MDR)
Ref WPM2Model EDP-TSRef 4020000426Model VaniaRef 4020000526Model Venus-NeoRef 4020000126Ref 4020000726Model Venus
Identity
- Trade Name
- EDP-TS EUDAMED
- Device Name
- Ventilator EUDAMED
- Model / Reference
- EDP-TS EUDAMEDWPM2 EUDAMEDVania EUDAMED4020000426 EUDAMEDVenus-Neo EUDAMED4020000526 EUDAMED4020000126 EUDAMEDVenus EUDAMED4020000726 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-62617867CL EUDAMEDD-62617867EDP-TSLXZG EUDAMEDD-62617867VaniaA3WQ EUDAMEDD-62617867Venus-NeoTD94 EUDAMEDD-62617867VenusD76E EUDAMED
- Basic UDI-DI
- B-62617867CL EUDAMEDB-62617867EDP-TSLXZG EUDAMEDB-62617867VaniaA3WQ EUDAMEDB-62617867Venus-NeoTD94 EUDAMEDB-62617867VenusD76E EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMEDZ1203010503 NEONATAL/PAEDIATRIC PULMONARY VENTILATORS EUDAMEDZ1203010502 ADULT PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMEDEUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ventilator by Ehya Darman Pishrafteh — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-62617867CL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ehya Darman Pishrafteh
- EUDAMED SRN
- IR-MF-000040524
- Authorised Representative
- CERT3GLOBAL, UNIPESSOAL, LDA. PT-AR-000037982
Sources (6)
- EUDAMED b2ca74c3-3d9d-4843-ab89-a9d5bba2c4e8 61 fields · synced Jul 27, 2026
- EUDAMED ec424285-1f79-41a6-bdee-2aa5c7d7722c 61 fields · synced May 17, 2026
- EUDAMED 8660ee1a-092b-4178-be68-1a3efcca9b12 61 fields · synced Jul 9, 2026
- EUDAMED 37982408-8b7e-42af-9534-48bccfaca84a 61 fields · synced Jul 15, 2026
- EUDAMED cafee51c-1d51-4c3b-bef0-8cd920e127bd 61 fields · synced Jul 19, 2026
- EUDAMED 1d56349a-7dd8-4adc-8c55-95e9e8fdf6fa 61 fields · synced Jul 27, 2026