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ExtendSURE HB610

by Canterbury Scientific, Ltd.

ExtendSURE HB610 is a Class II device made by Canterbury Scientific, Ltd., listed in FDA GUDID since 20 Sep 2018 (UDI-DI 09421902348020), 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 Number09421902348020 UDI-DI Date20 Sep 2018ListedStatusListed 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  • Withdrawn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
ExtendSURE
Generic name
Multiple haemoglobin subtype IVD, control
Model / reference
HB610
Primary DI / UDI-DI
09421902348020
FDA product code
JCM
GMDN term
Multiple haemoglobin subtype IVD, control
Device class
Class II
Regulation number
864.7415
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple haemoglobin subtype IVD, control

Similar devices

Other devices filed under FDA product code JCM (Control, Hemoglobin, Abnormal).

Other devices from Canterbury Scientific, Ltd.

See all devices from Canterbury Scientific, Ltd. →

Properties

  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)