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Monifold 193117

by Argon Medical Devices, Inc.

Ref 193117

Monifold 193117 is a device classified as Class IIa in the EU and Class II in the US made by Argon Medical Devices, Inc., registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI B-20886333207026), cleared under FDA 510(k) K915301 on 11 Dec 1992 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 20886333207026), 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) K915301

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-20886333207026 Basic UDI-DI 20886333207026UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20886333207026 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK915301 Date11 Dec 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20886333207026 registered 10 Jun 2026 Active
  • FDA 510(k) K915301 decided 11 Dec 1992 Active
  • FDA GUDID UDI-DI 20886333207026 listed 9 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K915301
  2. Listed FDA GUDID 20886333207026
  3. Registered EUDAMED B-20886333207026

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  • Withdrawn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
Monifold
Generic name
Fluid transfer set, general-purpose
Model / Ref / Catalog
193117
Primary DI / UDI-DI
20886333207026 EUDAMED
00886333207022 GUDID
Basic UDI-DI
B-20886333207026
510(k) Number
FDA product code
DTL
EMDN code
A0680 Drainage and fluid collection devices - accessories
GMDN term
Fluid transfer set, general-purpose
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.4290
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20886333207026
GUDID
00886333207022
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 20886333207026; FDA GUDID lists 00886333207022), 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: Fluid transfer set, general-purpose

Cleared under the same submission (K915301)

and 1 more cleared under K915301

Similar devices in this category

Other devices filed under DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES.

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

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