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Neumovent GraphNet Advance

by Tecme Corporation

Ref 1081A1Model GRAPHNET ADVANCE

Neumovent GraphNet Advance is a device classified as Class IIb in the EU and Class II in the US made by Tecme Corporation, registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-07798148080093) and listed in FDA GUDID since 29 Oct 2015 (UDI-DI 07798148080093), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07798148080093 Basic UDI-DI 07798148080093UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07798148080093 UDI-DI Date29 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07798148080093 registered 27 May 2026 Active
  • FDA GUDID UDI-DI 07798148080093 listed 29 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07798148080093
  2. Registered EUDAMED B-07798148080093

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Neumovent
Generic name
Neonatal/adult intensive-care ventilator
Device name
Neumovent Graphnet Advance
Model / reference
GraphNet Advance, 1081A1
Primary DI / UDI-DI
07798148080093
Basic UDI-DI
B-07798148080093
FDA product code
CBK
EMDN code
Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
GMDN term
Neonatal/adult intensive-care ventilator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5895
EU registration type
Legacy device (under a directive)
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Neonatal/adult intensive-care ventilator

Similar devices in this category

Other devices filed under ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS.

Properties

  • Administering medicine
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)