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Head-worn light

by Bistos Co., Ltd. 2 variants

Ref BT-410A

Head-worn light (BT-410A) is a Class I device made by Bistos Co., Ltd., registered in EUDAMED on 1 Dec 2025 (Basic UDI-DI 88000123MEHL04109Z) and listed in FDA GUDID since 7 Jun 2021 (UDI-DI 08800012341007), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000123MEHL04109Z Basic UDI-DI 08800012341007UDI-DIDate1 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08800012341007 UDI-DI Date7 Jun 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000123MEHL04109Z registered 1 Dec 2025 Active
  • FDA GUDID UDI-DI 08800012341007 listed 7 Jun 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800012341007
  2. Registered EUDAMED 88000123MEHL04109Z

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Head-worn lamp
Model / Ref / Catalog
BT-410A, CTD-HL-001
Primary DI / UDI-DI
08800012341007
Basic UDI-DI
88000123MEHL04109Z
Direct marketing DI
08800012341007
FDA product code
KYT
EMDN code
Z129004 Light sources
GMDN term
Head-worn lamp
Device class
Class I
Regulation number
880.6350
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Manufacturer details

EUDAMED SRN
KR-MF-000035951
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Premarket exempt
Other properties (24, all answered No)