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FibriJet

by Micromedics, Inc. 27 variants

Ref SA-3650

FibriJet (SA-3650) is an open-surgery adhesive/sealant applicator (EU MDD Class IIa; FDA Class II; FDA product code FMF, Syringe, Piston) made by Micromedics, Inc., registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI B-10815634021133) and listed in FDA GUDID since 1 Mar 2021 (UDI-DI 10815634021133), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10815634021133 Basic UDI-DI Date30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10815634021133 UDI-DI Date1 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10815634021133 registered 30 Mar 2026 Active
  • FDA GUDID UDI-DI 10815634021133 listed 1 Mar 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10815634021133
  2. Registered EUDAMED B-10815634021133

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Open-surgery adhesive/sealant applicator, dual-channel
Model / reference
SA-3650
Primary DI / UDI-DI
10815634021133, 00815634021136
Basic UDI-DI
B-10815634021133, B-00815634021136
FDA product code
FMF
EMDN code
A020199 Syringes, single-use - other
GMDN term
Open-surgery adhesive/sealant applicator, dual-channel
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5860
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000018365
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under SYRINGES, SINGLE-USE - OTHER.

Other devices from Micromedics, Inc.

See all devices from Micromedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)