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Novii Patch [BOX OF 10]

by Datex-Ohmeda Inc.

Ref MN-WP-10

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8406821BUG00146H9 Basic UDI-DI 00195278537188UDI-DIDate27 May 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Novii Patch
Model / Reference
MN-WP-10
Primary DI / UDI-DI
00195278537188
Basic UDI-DI
8406821BUG00146H9
Direct Marketing DI
00195278537188
EMDN Code
Z1208010485 Cardiotocographic telemetry instruments - consumables
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000002206
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from Datex-Ohmeda Inc.

See all devices from Datex-Ohmeda Inc. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No