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AV-S Anaesthesia Ventilator
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 5011306Model AV-S
Identity
- Trade Name
- AV-S Anaesthesia Ventilator EUDAMEDPenlon FDA UDI
- Generic Name
- Anaesthesia ventilator FDA UDI
- Device Name
- Anaesthesia Ventilator EUDAMED
- Model / Reference
- AV-S EUDAMED5011306 EUDAMEDAV-S Combined FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051977000048 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051977000048 EUDAMED
- 510(k) Number
- K051222 FDA UDI
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Anaesthesia ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AV-S Anaesthesia Ventilator by Penlon Limited — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051222 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-05051977000048 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Penlon Limited
- EUDAMED SRN
- GB-MF-000025115
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED cc64d13b-5f1e-41d6-86cd-50bcb506f068 61 fields · synced Jun 19, 2026
- FDA UDI fffc0b96-7cd5-4bd4-95a7-da766f717093 34 fields · synced May 30, 2026
- FDA 510(k) K051222 1 fields · synced May 18, 2026