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DeepHealth AI Node

by DeepHealth, Inc. 2 variants

Ref V.1.y.zModel 1.y.z

DeepHealth AI Node (V.1.y.z) is a Class IIb device made by Deephealth, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 08600051440PAIL4), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08600051440PAIL4 Basic UDI-DI 00860014963711UDI-DIDate28 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
DeepHealth ProstateAI
Model / reference
1.y.z, V.1.y.z
Primary DI / UDI-DI
00860014963711
Basic UDI-DI
08600051440PAIL4
EMDN code
Z119082 Various bioimaging and radiotherapy instruments - software accessories
Device class
Class IIb
Special device type
Software
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000051664
Authorised representative
MedEnvoy Global BV NL-AR-000024028

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Properties

Other properties (14, all answered No)