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Infuset-190

by EMED Technologies Corporation

Ref FP-0010008

Infuset-190 (FP-0010008) 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 26 Oct 2026 (Basic UDI-DI B-00817708020397), cleared under FDA 510(k) K140133 on 15 May 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00817708020397), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140133

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00817708020397 Basic UDI-DI 00817708020397UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817708020397 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140133 Date15 May 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00817708020397 registered 26 Oct 2026 Active
  • FDA 510(k) K140133 decided 15 May 2014 Active
  • FDA GUDID UDI-DI 00817708020397 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140133
  2. Listed FDA GUDID 00817708020397
  3. Registered EUDAMED B-00817708020397

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  • Withdrawn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
Infuset
Generic name
Mechanical infusion pump administration set
Device name
Infuset-190, Infuset flow control infusion set
Model / Ref / Catalog
FP-0010008, Infuset-190
Primary DI / UDI-DI
00817708020397 EUDAMED
00817708020403 GUDID
Basic UDI-DI
B-00817708020397
510(k) Number
FDA product code
FPA
EMDN code
A030104 Flow regulators
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
Length — 51.76 Centimeter
Total Volume — 0.14 Milliliter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FP-0010008
GUDID
Infuset-190
Primary DI / UDI-DIEUDAMED
00817708020397
GUDID
00817708020403
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00817708020397; FDA GUDID lists 00817708020403), 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 (K140133)

and 6 more cleared under K140133

Similar devices in this category

Other devices filed under FLOW REGULATORS.

Other devices from EMED Technologies Corporation

See all devices from EMED Technologies Corporation →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)