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Helix Test

by W&H Sterilization Srl

Ref T800206X, T800207XModel 35362

Helix Test (T800206X) is a medical device (EU MDR Class I; EMDN category sterilisation devices (excluding cat. d - z)) made by W&H Sterilization Srl, registered in EUDAMED on 19 Jan 2024 (Basic UDI-DI ++E30835362GJ), 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 Number++E30835362GJ Basic UDI-DI Date19 Jan 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  • Withdrawn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
35362, T800206X, T800207X
Primary DI / UDI-DI
+E308T800206X0F, +E308T800207X0G
Basic UDI-DI
++E30835362GJ
EMDN code
S9099 Sterilisation devices (excluding cat. d - z) - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000008237

Similar devices in this category

Other devices filed under STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER.

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Properties

Other properties (14, all answered No)