← Back to catalogue
Ventilators
EUDAMEDClass IIb (EU MDR)
Ref A01Model AgVa Pro , AgVa Pro +, AgVa Intelli ,AgVa Emergency , AgVa Home & AgVa One Ref A02
Identity
- Device Name
- Ventilators EUDAMED
- Model / Reference
- AgVa Pro , AgVa Pro +, AgVa Intelli ,AgVa Emergency , AgVa Home & AgVa One EUDAMEDA01 EUDAMEDA02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908022258008 EUDAMED08908022258039 EUDAMED
- Basic UDI-DI
- 8908022258AVAXX9G EUDAMED
- Direct Marketing DI
- 08908022258008 EUDAMED08908022258039 EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Ventilators by AgVa Healthcare — Class IIb — 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 | 8908022258AVAXX9G | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AgVa Healthcare
- EUDAMED SRN
- IN-MF-000036367
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 39d992d9-4b2c-4c6d-9f46-a70a1e5d605d 61 fields · synced Jul 28, 2026
- EUDAMED deb5ed99-8034-46b8-bdf2-2432711afcba 61 fields · synced May 17, 2026