Skip to content

Bt-410A

by Bistos Co., Ltd.

Bt-410A (CTD-HL-001) is a Class I device made by Bistos Co., Ltd., listed in FDA GUDID since 25 May 2018 (UDI-DI 00887529000342), 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 Number00887529000342 UDI-DI Date25 May 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  • Withdrawn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

Generic name
Head-worn lamp
Model / Ref / Catalog
BT-410A, CTD-HL-001
Primary DI / UDI-DI
00887529000342
FDA product code
HPP
GMDN term
Head-worn lamp
Device class
Class I
Regulation number
886.4335
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Head-worn lamp

Other devices from Bistos Co., Ltd.

See all devices from Bistos Co., Ltd. →

Properties

  • Premarket exempt
Other properties (14, all answered No)