← Back to catalogue
Sigma Delta MRI Vaporizer / Halothane
EUDAMEDClass IIb (EU MDR)
Ref 410502H-MModel Sigma Delta MRI
Identity
- Trade Name
- Sigma Delta MRI Vaporizer / Halothane EUDAMED
- Device Name
- Halothane Anaesthesia Vaporizer EUDAMED
- Model / Reference
- Sigma Delta MRI EUDAMED410502H-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051977002059 EUDAMED
- Basic UDI-DI
- B-05051977002059 EUDAMED
- EMDN Code
- Z1203010180 ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Sigma Delta MRI Vaporizer / Halothane 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-05051977002059 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Penlon Limited
- EUDAMED SRN
- GB-MF-000025115
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 7999d244-4bbe-4ec0-a029-725e7ed227ce 61 fields · synced Jun 20, 2026