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Auramine-Rhodamine Solution

by BaSO Biotech Co., LTD.. 4 variants

Ref TRNX-09A

Active European Union

CE IVDR

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/IVDR Number471988911MicrobiologyZM Basic UDI-DI 04719889110521UDI-DIDate9 Jun 2022RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Microbiology
Model / Reference
TRNX-09A
Primary DI / UDI-DI
04719889110521
Basic UDI-DI
471988911MicrobiologyZM
Direct Marketing DI
04719889110521
EMDN Code
W0104010804 Stains
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000018809
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from BaSO Biotech Co., LTD..

See all devices from BaSO Biotech Co., LTD.. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No