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Dsub

by Substrate HD

Ref H005

Dsub (H005) is a Class I device made by Substrate Hd, registered in EUDAMED on 12 Apr 2024 (Basic UDI-DI 3770019196H005TB), active as of 22 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770019196H005TB Basic UDI-DI 03770019196045UDI-DIDate12 Apr 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
H005
Primary DI / UDI-DI
03770019196045
Basic UDI-DI
3770019196H005TB
Direct marketing DI
03770019196045
EMDN code
Z1205078099 Instruments for cardiological polygraphy - hardware accessories - other
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000507

Similar devices in this category

Other devices filed under CARDIOGRAPHY INSTRUMENTS.

Other devices from Substrate Hd

Properties

Other properties (14, all answered No)