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INTRAN Plus

by Utah Medical Products, Inc. 8 variants

Ref IUP-700

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++H671CE005IIACE Basic UDI-DI H671IUP7000UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberH671IUP7000 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-2200-2008 FDA Unclassified (pre-2012) initiated 16 Jun 2008

    Possibility of compromised package sterility prior to the expiration date.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Intran
Generic Name
Intrapartum pressure monitoring catheter
Model / Ref / Catalog
IUP-700, Plus
Primary DI / UDI-DI
H671IUP7000
Basic UDI-DI
++H671CE005IIACE
510(k) Number
FDA Product Code
HFN
EMDN Code
U100199 Obstetrical catheters - other
GMDN Term
Intrapartum pressure monitoring catheter
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
884.2700
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
IUP-700
GUDID
Plus
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K961424)

Other devices from Utah Medical Products, Inc.

See all devices from Utah Medical Products, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No