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Microlife MedGem

by Microlife USA, Inc.

Microlife MedGem is a Class II device made by Microlife USA, Inc., listed in FDA GUDID since 14 Jun 2023 (UDI-DI 00810445030001), 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 Number00810445030001 UDI-DI Date14 Jun 2023ListedStatusListed 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  • Withdrawn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
Microlife
Generic name
Indirect calorimeter
Model / reference
MedGem
Primary DI / UDI-DI
00810445030001
FDA product code
BZL
GMDN term
Indirect calorimeter
Device class
Class II
Regulation number
868.1730
GUDID distribution status
In Commercial Distribution

Related devices

Category: Indirect calorimeter

Similar devices

Also classified as Indirect calorimeter.

Similar devices

Other devices filed under FDA product code BZL (Computer, Oxygen-Uptake).

Other devices from Microlife USA, Inc.

See all devices from Microlife USA, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)