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OPTFlow OPT12404U

by EMED Technologies Corporation

Ref OPT12404U

OPTFlow OPT12404U is a device classified as Class IIa in the EU and Class II in the US made by EMED Technologies Corporation, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI B-00817708022414), cleared under FDA 510(k) K140131 on 3 Apr 2014 and listed in FDA GUDID since 21 Mar 2018 (UDI-DI 00817708022414), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140131

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00817708022414 Basic UDI-DI 00817708022414UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817708022414 UDI-DI Date21 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK140131 Date3 Apr 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00817708022414 registered 9 Oct 2026 Active
  • FDA 510(k) K140131 decided 3 Apr 2014 Active
  • FDA GUDID UDI-DI 00817708022414 listed 21 Mar 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140131
  2. Listed FDA GUDID 00817708022414
  3. Registered EUDAMED B-00817708022414

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
OPTFlow
Generic name
Mechanical infusion pump administration set
Device name
OPTFlow SUB-Q 1 Needle set 24ga TW x 4mm 70cm Tubing w/safety mechanism
Model / Ref / Catalog
OPT12404U
Primary DI / UDI-DI
00817708022414 EUDAMED
00817708022421 GUDID
Basic UDI-DI
B-00817708022414
510(k) Number
FDA product code
FPA
EMDN code
Z12030385 Infusion instruments - consumables
GMDN term
Mechanical infusion pump administration set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5440
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 24 Gauge
Length — 4 Millimeter
Length — 70 Centimeter
Total Volume — 0.4 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00817708022414
GUDID
00817708022421
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00817708022414; FDA GUDID lists 00817708022421), so their flags are not compared. 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.

Related devices

Category: Mechanical infusion pump administration set

Cleared under the same submission (K140131)

and 8 more cleared under K140131

Similar devices in this category

Other devices filed under INFUSION INSTRUMENTS - CONSUMABLES.

Other devices from EMED Technologies Corporation

See all devices from EMED Technologies Corporation →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)