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LinkBio Instrument MCGTEI

by LinkBio Corp.

LinkBio Instrument MCGTEI is a Class I device made by LinkBio Corp., listed in FDA GUDID since 13 May 2021 (UDI-DI 00810022401545), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810022401545 UDI-DI Date13 May 2021ListedStatusListed 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  • Withdrawn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
LinkBio Instrument
Generic name
Instrument tray, reusable
Model / reference
MCGTEI
Primary DI / UDI-DI
00810022401545
FDA product code
FSM
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

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Other devices filed under Instrument tray, reusable.

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
Other properties (12, all answered No)