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Mahurkar 8830415003

by Mozarc Medical US LLC

Ref 8830415003Model Mahurkar Acute Dual Lumen Catheter

Mahurkar 8830415003 is a device classified as Class IIa in the EU and Class II in the US made by Mozarc Medical US LLC, registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI B-20884521005171) and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 20884521005171), 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-20884521005171 Basic UDI-DI 20884521005171UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20884521005171 UDI-DI Date22 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-20884521005171 registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 20884521005171 listed 22 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 20884521005171
  2. Registered EUDAMED B-20884521005171

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  • Withdrawn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
MAHURKAR™Acute Dual Lumen Catheter Kit Curved Extensions11.5 Fr/Ch (3.8 mm) x 16 cm EUDAMED
Mahurkar GUDID
Generic name
Double-lumen haemodialysis catheter, nonimplantable
Model / reference
8830415003, Mahurkar Acute Dual Lumen Catheter
Primary DI / UDI-DI
20884521005171 EUDAMED
10884521005174 GUDID
Basic UDI-DI
B-20884521005171
FDA product code
FOZ
EMDN code
F900201 Temporary hemodialysis catheters and kits
GMDN term
Double-lumen haemodialysis catheter, nonimplantable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5200
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 16 Centimeter
Catheter Gauge — 11.5 French

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20884521005171
GUDID
10884521005174
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists 20884521005171; FDA GUDID lists 10884521005174), 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: Double-lumen haemodialysis catheter, nonimplantable

Similar devices in this category

Other devices filed under TEMPORARY HEMODIALYSIS CATHETERS AND KITS.

Other devices from Mozarc Medical US LLC

See all devices from Mozarc Medical US LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)