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Novarhiz

by Novatex Medical SA 9 variants

Ref 03701422901445, 03701422901377, 03701422905306, 03701422905283, 03701422901452, 03701422901407, 03701422901469, 03701422905290, 03701422901438, 03701422901322, 03701422901476, 03701422905276, 03701422905245, 03701422901353, 03701422905252, 03701422901360

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37014229NOVATHANEHY Basic UDI-DI Date18 Nov 2025RegisteredStatusActive

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  • Withdrawn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
Novathane
Model / Reference
03701422901445, 03701422901377, 03701422905306, 03701422905283, 03701422901452, 03701422901407, 03701422901469, 03701422905290, 03701422901438, 03701422901322, 03701422901476, 03701422905276, 03701422905245, 03701422901353, 03701422905252, 03701422901360
Primary DI / UDI-DI
03701422901445, 03701422901377, 03701422905306, 03701422905283, 03701422901452, 03701422901407, 03701422901469, 03701422905290, 03701422901438, 03701422901322, 03701422901476, 03701422905276, 03701422905245, 03701422901353, 03701422905252, 03701422901360
Basic UDI-DI
37014229NOVATHANEHY
EMDN Code
M030504 Immobilisation systems, mouldable under cold and hot temperatures
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014276

Other devices from Novatex Medical SA

See all devices from Novatex Medical SA →

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