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Amazrock Amaz-HC1001401

by Amazrock Pte. Ltd.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08883000001749 UDI-DI Date30 Jun 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Amazrock
Generic Name
Infrared patient thermometer, skin
Model / Reference
Amaz-HC1001401
Primary DI / UDI-DI
08883000001749
510(k) Number
FDA Product Code
FLL
GMDN Term
Infrared patient thermometer, skin
Device Class
Class II
Regulation Number
880.2910
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K131243)

Show all (12)

Properties

  • Serial Number

Other properties (13)

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