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Mindray XMR0047

by GaleMed Xiamen Co., Ltd.

Mindray XMR0047 (040-001802-00) is a Class I device made by GaleMed Xiamen Co., Ltd., listed in FDA GUDID since 23 Jun 2025 (UDI-DI 06923980115554), 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 Number06923980115554 UDI-DI Date23 Jun 2025ListedStatusListed 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  • Withdrawn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
Mindray
Generic name
Breathing circuit bag, reusable
Model / Ref / Catalog
XMR0047, 040-001802-00
Primary DI / UDI-DI
06923980115554
FDA product code
BTC
GMDN term
Breathing circuit bag, reusable
Device class
Class I
Regulation number
868.5320
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Breathing circuit bag, reusable.

Other devices from GaleMed (Xiamen) Co., Ltd.

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)