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K-Systems G210 InviCell US Incubator

by Research Instruments, Ltd.

K-Systems G210 InviCell US Incubator (K61500) is a Class II device made by Research Instruments, Ltd., listed in FDA GUDID since 19 Mar 2019 (UDI-DI 05060554120307), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060554120307 UDI-DI Date19 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
K-Systems
Generic name
Assisted reproduction heater/incubator
Model / Ref / Catalog
G210 InviCell US Incubator, K61500
Primary DI / UDI-DI
05060554120307
FDA product code
PUB
GMDN term
Assisted reproduction heater/incubator
Device class
Class II
Regulation number
884.6120
GUDID distribution status
In Commercial Distribution

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Category: Assisted reproduction heater/incubator

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)