Identity
- Trade Name
- Prima 320 Anaesthetic Machine EUDAMED
- Device Name
- Anaesthesia Workstation EUDAMED
- Model / Reference
- 5011302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051977000581 EUDAMED
- Basic UDI-DI
- B-05051977000581 EUDAMED
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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 320 Anaesthetic 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-05051977000581 | 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 64fbafb2-7beb-47ca-909d-af6df0fc1a8c 61 fields · synced Jul 11, 2026