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TipTraQ TTQ001

by Pranaq Pte., Ltd. 5 variants

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 Number08885021950013 UDI-DI Date18 May 2026ListedStatusListed 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  • Withdrawn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
TipTraQ
Generic Name
Wearable multiple physiological parameter recorder, reusable
Model / Reference
TTQ001
Primary DI / UDI-DI
08885021950013
510(k) Number
FDA Product Code
MNR
GMDN Term
Wearable multiple physiological parameter recorder, reusable
Device Class
Class II
Regulation Number
868.2375
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K243268)

Other devices from Pranaq Pte., Ltd.

See all devices from Pranaq Pte., Ltd. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No