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iFlash-Prolactin C86013

by Shenzhen YHLO Biotech Co., Ltd.

Ref C86013

iFlash-Prolactin C86013 is a device classified as Class B in the EU and Class I in the US made by Shenzhen YHLO Biotech Co., Ltd., registered in EUDAMED on 25 Apr 2023 (Basic UDI-DI 692591270014GU) and listed in FDA GUDID since 26 Oct 2022 (UDI-DI 06925912718772), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number692591270014GU Basic UDI-DI 06925912718772UDI-DIDate25 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06925912718772 UDI-DI Date26 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 692591270014GU registered 25 Apr 2023 Active
  • FDA GUDID UDI-DI 06925912718772 listed 26 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06925912718772
  2. Registered EUDAMED 692591270014GU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
iFlash-Prolactin
Generic name
Prolactin IVD, kit, chemiluminescent immunoassay
Model / reference
C86013
Primary DI / UDI-DI
06925912718772
Basic UDI-DI
692591270014GU
FDA product code
CFT
EMDN code
W0102050108 Prolactin
GMDN term
Prolactin IVD, kit, chemiluminescent immunoassay
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1625
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class I

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

Related devices

Category: Prolactin IVD, kit, chemiluminescent immunoassay

Similar devices in this category

Other devices filed under PROLACTIN.

Other devices from Shenzhen YHLO Biotech Co., Ltd.

See all devices from Shenzhen YHLO Biotech Co., Ltd. →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)