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Sinurep SR20100-00

by Medax Unipersonale Srl

Sinurep SR20100-00 is a Class I device made by Medax Unipersonale Srl, listed in FDA GUDID since 8 Mar 2018 (UDI-DI 08056515888093), 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 Number08056515888093 UDI-DI Date8 Mar 2018ListedStatusListed 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  • Withdrawn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
Sinurep
Generic name
Imaging lesion localization marker, external, single-use
Model / reference
SR20100-00
Primary DI / UDI-DI
08056515888093
FDA product code
MIJ
GMDN term
Imaging lesion localization marker, external, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Imaging lesion localization marker, external, single-use

Similar devices in this category

Other devices filed under Imaging lesion localization marker, external, single-use.

Other devices from Medax Unipersonale Srl

See all devices from Medax Unipersonale Srl →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)