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R-test Cryptococcus Capsular Polysaccharide Rapid Test

by Lab Diagnostic Systems (SMC) Pvt. Ltd. Pakistan EUDAMED

Ref R-39050Model 50 Tests

EMDN W0105060303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08964004385001 Basic UDI-DIDate4 Apr 2025RegisteredStatusActive

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 25 Oct 2026

Model / Reference
50 Tests, R-39050
Primary DI / UDI-DI
08964004385001
Basic UDI-DI
B-08964004385001
EMDN Code
W0105060303 Cryptococcus
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
PK-MF-000046055
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Lab Diagnostic Systems (SMC) Pvt. Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED fcb98ba6-0f63-4435-a18c-40c5d636c4bc 61 fields · synced 25 Oct 2026