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HIT laser HITSDX Green

by C-Rad Positioning AB

HIT laser HITSDX Green is a Class I device made by C-Rad Positioning AB, listed in FDA GUDID since 16 Jul 2020 (UDI-DI 17350005280069), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17350005280069 UDI-DI Date16 Jul 2020ListedStatusListed 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  • Withdrawn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
HIT laser
Generic name
Laser patient positioning system
Model / reference
HITSDX Green
Description
Laser Box Product Number: HW004 laser Product number: HW050
Primary DI / UDI-DI
17350005280069
FDA product code
IWE
GMDN term
Laser patient positioning system
Device class
Class I
Regulation number
892.5780
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)