Sectra Calibration Unit 2

Sectra Calibration Unit 2 is a Class I device made by Sectra AB, listed in FDA GUDID since 7 Nov 2022 (UDI-DI 07350092810395), 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07350092810395 UDI-DI	Date7 Nov 2022Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 07350092810395

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Sectra Calibration Unit
Generic name: General-purpose diagnostic x-ray phantom, test object
Model / reference: 2

Primary DI / UDI-DI: 07350092810395
FDA product code: LHO
GMDN term: General-purpose diagnostic x-ray phantom, test object

Device class: Class I
Regulation number: 892.1940
GUDID distribution status: In Commercial Distribution

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See all devices from Sectra AB →

Properties

Premarket exempt
Lot / batch number

Other properties (13, all answered No)