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My Dose Coach 1.x.x

by Sanofi-Aventis Deutschland GmbH

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04030685900001 UDI-DI Date2 Jun 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) 510(k) NumberK171230 Date26 May 2017IssuedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k) · GUDID

Trade Name
My Dose Coach
Generic Name
Clinical decision management support software
Model / Reference
1.x.x
Primary DI / UDI-DI
04030685900001
510(k) Number
FDA Product Code
NDC
GMDN Term
Clinical decision management support software
Device Class
Class II
Regulation Number
868.1890
GUDID distribution status
Not in Commercial Distribution

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