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Namic 70058307

by Medline Industries, Inc.

Ref 70058307

Namic 70058307 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 20 Oct 2026 (Basic UDI-DI B-10193489065763) and listed in FDA GUDID since 26 Jul 2021 (UDI-DI 10193489065763), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10193489065763 Basic UDI-DI 10193489065763UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10193489065763 UDI-DI Date26 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10193489065763 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 10193489065763 listed 26 Jul 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10193489065763
  2. Registered EUDAMED B-10193489065763

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  • Withdrawn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
Manifold 3V Comp. Rh/Off Pg EUDAMED
Namic GUDID
Generic name
Invasive-pressure external transducer, single-use
Device name
DC323 - NAMIC_Disposable Blood Pressure Transducers
Model / Ref / Catalog
70058307
Primary DI / UDI-DI
10193489065763
Basic UDI-DI
B-10193489065763
FDA product code
DRS
EMDN code
Z1203020301 Invasive blood pressure monitoring instruments
GMDN term
Invasive-pressure external transducer, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2850
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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: Invasive-pressure external transducer, single-use

Similar devices in this category

Other devices filed under INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS.

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)