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MDHC 1 pair

by MDHC Life Technologies (Kunshan) Co., LTD.

MDHC 1 pair is a shoe cover (FDA Class I; FDA product code FXP, Cover, Shoe, Operating-Room) made by MDHC Life Technologies (Kunshan) Co., LTD., listed in FDA GUDID since 6 Jul 2023 (UDI-DI 06974669350209), 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 Number06974669350209 UDI-DI Date6 Jul 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  • Withdrawn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
Mdhc
Generic name
Shoe cover
Model / reference
1 pair
Primary DI / UDI-DI
06974669350209
FDA product code
FXP
GMDN term
Shoe cover
Device class
Class I
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FXP (Cover, Shoe, Operating-Room).

Other devices from MDHC Life Technologies (Kunshan) Co., LTD.

See all devices from MDHC Life Technologies (Kunshan) Co., LTD. →

Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)