Skip to content

Sub-Q Sub-260

by EMED Technologies Corporation

Ref SUB-260

Sub-Q Sub-260 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 27 Oct 2026 (Basic UDI-DI B-00817708021493), cleared under FDA 510(k) K140131 on 3 Apr 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00817708021493), 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) K140131

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-00817708021493 Basic UDI-DI 00817708021493UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817708021493 UDI-DI Date23 Sep 2016ListedStatusListed 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-00817708021493 registered 27 Oct 2026 Active
  • FDA 510(k) K140131 decided 3 Apr 2014 Active
  • FDA GUDID UDI-DI 00817708021493 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140131
  2. Listed FDA GUDID 00817708021493
  3. Registered EUDAMED B-00817708021493

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  • Withdrawn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
Sub EUDAMED
Sub-Q GUDID
Generic name
Mechanical infusion pump administration set
Model / Ref / Catalog
SUB-260
Primary DI / UDI-DI
00817708021493 EUDAMED
00817708021509 GUDID
Basic UDI-DI
B-00817708021493
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
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 27 Gauge
Length — 9 Millimeter
Length — 91.4 Centimeter
Total Volume — 0.4 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00817708021493
GUDID
00817708021509
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00817708021493; FDA GUDID lists 00817708021509), 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 (18, all answered No)