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Fielmann COMFORT 084 FLEX CL_60088

by Fielmann Group AG

Fielmann COMFORT 084 FLEX CL_60088 is a Class I device made by Fielmann Group AG, listed in FDA GUDID since 19 Dec 2025 (UDI-DI 04066209012028), 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 Number04066209012028 UDI-DI Date19 Dec 2025ListedStatusListed 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  • Withdrawn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
Fielmann
Generic name
Spectacle frame
Model / reference
COMFORT 084 FLEX CL_60088
Primary DI / UDI-DI
04066209012028
FDA product code
HQZ
GMDN term
Spectacle frame
Device class
Class I
Regulation number
886.5842
GUDID distribution status
In Commercial Distribution

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Properties

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