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Chemdye™ KH2X15-5.3Y/P

by Terragene S.A.

Ref KH2X15-5.3Y/P

Chemdye™ KH2X15-5.3Y/P is a Class I device made by Terragene S.A., registered in EUDAMED on 5 Nov 2025 (Basic UDI-DI 779816467CI5L), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number779816467CI5L Basic UDI-DI 07798164679554UDI-DIDate5 Nov 2025RegisteredStatusActive

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  • Withdrawn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

Device name
Terragene® Cleaning, disinfection and sterilization indicators
Model / reference
KH2X15-5.3Y/P
Primary DI / UDI-DI
07798164679554
Basic UDI-DI
779816467CI5L
EMDN code
S9080 Devices for sterilisation (excluding cat. d - z) - accessories
Device class
Class I
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
AR-MF-000047833
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

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

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Properties

Other properties (14, all answered No)