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Insighters iS-PF1

by Shenzhen Insighters Medical Technology Co., Ltd.

Insighters iS-PF1 is a Class I device made by Shenzhen Insighters Medical Technology Co., Ltd., listed in FDA GUDID since 6 Jan 2023 (UDI-DI 06970831723253), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970831723253 UDI-DI Date6 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Insighters
Generic name
Endoscopic video image display unit
Model / reference
iS-PF1
Primary DI / UDI-DI
06970831723253
FDA product code
OUG
GMDN term
Endoscopic video image display unit
Device class
Class I
Regulation number
880.6310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic video image display unit

Other devices from Shenzhen Insighters Medical Technology Co., Ltd.

See all devices from Shenzhen Insighters Medical Technology Co., Ltd. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)