Skip to content

BIOTRACE™ Instant Read Steam BI Process Challenge Device

by Terragene S.A.

Ref 73140

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number779816467CI5L Basic UDI-DI 07798375772631UDI-DIDate5 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  • Withdrawn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
Terragene® Cleaning, disinfection and sterilization indicators
Model / Reference
73140
Primary DI / UDI-DI
07798375772631
Basic UDI-DI
779816467CI5L
Direct Marketing DI
07798375772617
EMDN Code
S9080 Devices for sterilisation (excluding cat. d - z) - accessories
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

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

Other devices from Terragene S.A.

See all devices from Terragene S.A. →

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