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SMILE-100 System v4.8.0

by Niramai Health Analytix Private Limited

Listed FDA GUDID listing, no authorization on record

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 Number08908019450057 UDI-DI Date18 Feb 2025ListedStatusListed GUDID: 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  • Withdrawn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
SMILE-100 System
Generic Name
Infrared thermography interpretive software
Model / Ref / Catalog
v4.8.0
Primary DI / UDI-DI
08908019450057
510(k) Number
FDA Product Code
LHQ
GMDN Term
Infrared thermography interpretive software
Device Class
Class I
Regulation Number
884.2980
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared thermography interpretive software

Cleared under the same submission (K212965)

Other devices from Niramai Health Analytix Private Limited

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No