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Novacalm

by Kitozyme SA

Ref BK001

Novacalm (BK001) is a Class IIa device made by Kitozyme SA, registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-05430001270068), active as of 7 Nov 2026.

Active European Union

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05430001270068 Basic UDI-DI Date19 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Gastrap Direct
Model / reference
BK001
Primary DI / UDI-DI
05430001270068, 05430001270075
Basic UDI-DI
B-05430001270068, B-05430001270075
EMDN code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
BE-MF-000000109

Similar devices in this category

Other devices filed under ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS.

Other devices from Kitozyme SA

Properties

Other properties (12, all answered No)