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Gateway GTWY01

by Ncs Lab SRL

Gateway GTWY01 is a Class II device made by Ncs Lab SRL, listed in FDA GUDID since 14 Mar 2022 (UDI-DI 08051122041015), 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 Number08051122041015 UDI-DI Date14 Mar 2022ListedStatusListed 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  • Withdrawn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
Gateway
Generic name
Medical networking interface unit
Model / reference
GTWY01
Primary DI / UDI-DI
08051122041015
FDA product code
ISD
GMDN term
Medical networking interface unit
Device class
Class II
Regulation number
890.5360
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical networking interface unit

Similar devices in this category

Other devices filed under Medical networking interface unit.

Other devices from Ncs Lab SRL

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)