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Module PTA Hypnea

by Cidelec

Ref PR05Model Module PTA Hypnea

Module PTA Hypnea (PR05) is a Class I device made by Cidelec, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 376034480Pressure-H8M), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376034480Pressure-H8M Basic UDI-DI 03760344801448UDI-DIDate6 Nov 2026RegisteredStatusActive

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  • Withdrawn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
Module PTA Hypnea, PR05
Primary DI / UDI-DI
03760344801448
Basic UDI-DI
376034480Pressure-H8M
Direct marketing DI
03760344801448
EMDN code
Z129099 Various instruments for functional exploration and therapeutic interventions - other
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000011946

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER.

Other devices from Cidelec

See all devices from Cidelec →

Properties

Other properties (14, all answered No)