Identity
- Trade Name
- Prima 460 Anaesthesia Machine EUDAMEDPenlon FDA UDI
- Generic Name
- Anaesthesia workstation, general-purpose FDA UDI
- Device Name
- Prima 460 Anaesthetic Machine EUDAMED
- Model / Reference
- 5011305 EUDAMEDPrima 460 Anaesthetic Machine FDA UDI
Identifiers
- Catalog Number
- 5011305 FDA UDI
- Primary DI / UDI-DI
- 05051977000857 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051977000857 EUDAMED
- 510(k) Number
- K061102 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
- GMDN Term
- Anaesthesia workstation, general-purpose FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Market of Registration
- Poland 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
Prima 460 Anaesthesia Machine by Penlon Limited — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051977000857 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Penlon Limited
- EUDAMED SRN
- GB-MF-000025115
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED a3310232-e4d6-4bba-913a-36a0141b65a8 61 fields · synced Jul 21, 2026
- FDA UDI b0ec427d-c523-4796-9e0e-5281594e2172 35 fields · synced May 29, 2026