Identity
- Trade Name
- Prima 465 Anaesthesia Machine EUDAMED
- Device Name
- Prima 465 Anaesthesia Machine EUDAMED
- Model / Reference
- 5011301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051977000574 EUDAMED
- Basic UDI-DI
- B-05051977000574 EUDAMED
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prima 465 Anaesthesia Machine by Penlon Limited — 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-05051977000574 | 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 (1)
- EUDAMED e62bff68-2a0b-4145-aa62-370ef1b83e36 61 fields · synced Jul 14, 2026