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Time-lapse Incubator Capacity Expansion Module TL-16EX

by Hua Yue Medical Technology Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06975183900192 UDI-DI Date30 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Time-lapse Incubator Capacity Expansion Module
Generic Name
Assisted reproduction incubator/microscope camera system
Model / Reference
TL-16EX
Primary DI / UDI-DI
06975183900192
510(k) Number
FDA Product Code
MQG, MQK, MTX
GMDN Term
Assisted reproduction incubator/microscope camera system
Device Class
Class II
Regulation Number
884.6120, 884.6160, 884.6190
GUDID distribution status
In Commercial Distribution
Size
Weight — 60 Kilogram

Related devices

Cleared under the same submission (K242684)

Other devices from Hua Yue Medical Technology Co., Ltd.

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Properties

  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No