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Paraid Hcg-M04

by Nantong Egens Biology Technic Co., Ltd.

Ref HE01E0201

Paraid Hcg-M04 is a device classified as Class B in the EU and Class II in the US made by Nantong Egens Biology Technic Co., Ltd., registered in EUDAMED on 9 May 2026 (Basic UDI-DI 69375799yszy03G4), cleared under FDA 510(k) K123050 on 5 Feb 2013 and listed in FDA GUDID since 11 Aug 2023 (UDI-DI 06937579912370), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

17 Sep 2030

CE IVDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

510(k) K123050

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number69375799yszy03G4 Basic UDI-DI 06937579912370UDI-DIDate9 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06937579912370 UDI-DI Date11 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123050 Date5 Feb 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69375799yszy03G4 registered 9 May 2026 Active
  • FDA 510(k) K123050 decided 5 Feb 2013 Active
  • FDA GUDID UDI-DI 06937579912370 listed 11 Aug 2023 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

3 dated events

  1. Cleared FDA 510(k) K123050
  2. Listed FDA GUDID 06937579912370
  3. Registered EUDAMED 69375799yszy03G4

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Early Pregnancy Test EUDAMED
Paraid GUDID
Generic name
Human chorionic gonadotropin alpha-subunit IVD, calibrator
Model / reference
HE01E0201 EUDAMED
HCG-M04 GUDID
Primary DI / UDI-DI
06937579912370
Basic UDI-DI
69375799yszy03G4
510(k) Number
FDA product code
LCX
EMDN code
W0102160302 Hcg - rt & poc
GMDN term
Human chorionic gonadotropin alpha-subunit IVD, calibrator
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1155
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HE01E0201
GUDID
HCG-M04
Device classEUDAMED
Class B
GUDID
Class II

Device class is stated on each registry's own scale: Class B in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Human chorionic gonadotropin alpha-subunit IVD, calibrator

Cleared under the same submission (K123050)

and 8 more cleared under K123050

Similar devices in this category

Other devices filed under HCG - RT & POC.

Other devices from Nantong Egens Biology Technic Co., Ltd.

See all devices from Nantong Egens Biology Technic Co., Ltd. →

Properties

  • Single use
  • Self-testing
  • Professional testing
  • New device
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)