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Namic 91300007

by Medline Industries, Inc.

Ref 91300007

Namic 91300007 is a device classified as Class IIa in the EU and Class II in the US made by Medline Industries, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-10193489069006) and listed in FDA GUDID since 26 Jul 2021 (UDI-DI 10193489069006), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10193489069006 Basic UDI-DI 10193489069006UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10193489069006 UDI-DI Date26 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10193489069006 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 10193489069006 listed 26 Jul 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10193489069006
  2. Registered EUDAMED B-10193489069006

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  • Withdrawn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

Trade name
SET,IV,274CM,SPIKE,IV,VENT,ST EUDAMED
Namic GUDID
Generic name
Basic intravenous administration set, noninvasive
Device name
Disposable Stopcocks and Manifolds
Model / Ref / Catalog
91300007
Primary DI / UDI-DI
10193489069006
Basic UDI-DI
B-10193489069006
FDA product code
FPA
EMDN code
A030499 Administration kits - other
GMDN term
Basic intravenous administration set, noninvasive
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5440
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 108 Inch

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.

Related devices

Category: Basic intravenous administration set, noninvasive

Similar devices in this category

Other devices filed under ADMINISTRATION KITS - OTHER.

Other devices from Medline Industries, Inc.

See all devices from Medline Industries, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)