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One-Step HCG Pregnancy Test

by Shanghai Chemtron Biotech Co., Ltd.

Ref 6001C 6001S 6001D 6001BModel Cassette, Strip, Midstream, Urine Cup

Active European Union and United States

CE IVDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200133↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-CNM0000180726001MY Basic UDI-DI D-CNM0000180726001MYUDI-DIDate25 Dec 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK200133 Date13 Aug 2020IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDD Active

Specification

EUDAMED · 510(k)

Device Name
One-Step HCG Pregnancy Test
Model / Reference
Cassette, Strip, Midstream, Urine Cup, 6001C 6001S 6001D 6001B
Primary DI / UDI-DI
D-CNM0000180726001MY
Basic UDI-DI
B-CNM0000180726001MY
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000018072
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Self Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No