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Duroscope Hd-101

by FMD Co., Ltd.

Duroscope Hd-101 is a Class I device made by FMD Co., Ltd., listed in FDA GUDID since 9 Feb 2019 (UDI-DI 00863333000327), 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 Number00863333000327 UDI-DI Date9 Feb 2019ListedStatusListed 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  • Withdrawn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
Duroscope
Generic name
Endoscope video camera
Model / Ref / Catalog
HD-101
Primary DI / UDI-DI
00863333000327
FDA product code
FWL
GMDN term
Endoscope video camera
Device class
Class I
Regulation number
878.4160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope video camera

Other devices from FMD Co., Ltd.

See all devices from FMD Co., Ltd. →

Properties

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