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Daymark

by Long Island Technology Group, LLC EUDAMEDGUDID

Active European Union

Ref BFW 9070, BFW 9070NC, BFW 9070NB, BFW 9070NBNC, BFW 9070-OModel P003060

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0851610007P003060A3 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00851610007367 UDI-DIDate7 Aug 2020ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Daymark EUDAMED
Daymark Headlight System GUDID
Generic Name
Head-worn lamp
Model / Reference
P003060, BFW 9070, BFW 9070NC, BFW 9070NB, BFW 9070NBNC, BFW 9070-O
Primary DI / UDI-DI
00851610007367
Basic UDI-DI
0851610007P003060A3
FDA Product Code
KYT
EMDN Code
Z129004 Light sources
GMDN Term
Head-worn lamp
Device Class
Class I
Regulation Number
880.6350
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000014025
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Long Island Technology Group, LLC

See all devices from Long Island Technology Group, LLC →

Properties

  • Convenience Kit
  • Premarket Exempt
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No