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RapidBac™

by Silver Lake Research Corporation United States EUDAMED

Ref RB111

EMDN W0101060201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850031753105 Basic UDI-DIDate29 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
RapidBac™ Rapid Test for Detection of Bacteria - Pack of 10 Tests
Model / Reference
RB111
Primary DI / UDI-DI
00850031753105
Basic UDI-DI
B-00850031753105
EMDN Code
W0101060201 Urine single test strips (incl. tablets)
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
US-MF-000027373
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Silver Lake Research Corporation

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED ba87024c-a701-4572-ba82-725243f531a1 61 fields · synced 22 Oct 2026