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Incubator

by Changsha Yingtai Instrument Co., Ltd 9 variants

Ref I009Model PRP-Gel

Incubator (I009) is a microplate/tube/assay card incubator IVD (EU IVDR Class A; FDA Class I; FDA product code JTQ, Bath, Incubators/Water, All) made by Changsha Yingtai Instrument Co., Ltd, registered in EUDAMED on 17 Apr 2023 (Basic UDI-DI 697630191PRP-Gel4C) and listed in FDA GUDID since 1 Mar 2025 (UDI-DI 06976301910406), 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
United StatesGUDID listing GUDID Number06976301910406 UDI-DI Date1 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number697630191PRP-Gel4C Basic UDI-DI 06976301910406UDI-DIDate17 Apr 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697630191PRP-Gel4C registered 17 Apr 2023 Active
  • FDA GUDID UDI-DI 06976301910406 listed 1 Mar 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 697630191PRP-Gel4C
  2. Listed FDA GUDID 06976301910406

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  • Withdrawn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
Yingtai
Generic name
Microplate/tube/assay card incubator IVD
Model / reference
PRP-Gel, I009
Primary DI / UDI-DI
06976301910406
Basic UDI-DI
697630191PRP-Gel4C
Direct marketing DI
06976301910406
FDA product code
JTQ
EMDN code
W02069099 Various sample processing instruments - other
GMDN term
Microplate/tube/assay card incubator IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
866.2540
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
CN-MF-000034851
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Similar devices in this category

Other devices filed under VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER.

Other devices from Changsha Yingtai Instrument Co., Ltd

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Properties

  • Professional testing
  • IVD instrument
  • Premarket exempt
  • Manufacturing date
Other properties (22, all answered No)