Skip to content

Porges Coloplast AJ4176

by Coloplast A/S

Ref AJ4176

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089326358178H Basic UDI-DI 03600040927052UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03600040927052 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: not 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.

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  • Withdrawn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
ImaJin EUDAMED
Porges Coloplast GUDID
Generic Name
Polymeric ureteral stent
Device Name
ImaJin double loop ureteral stent kit in silicone
Model / Ref / Catalog
AJ4176
Primary DI / UDI-DI
03600040927052 EUDAMED
03600040197929 GUDID
Basic UDI-DI
57089326358178H
FDA Product Code
FAD
EMDN Code
U020302 Double loop ureteral stents
GMDN Term
Polymeric ureteral stent
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4620
Medical Purpose
Drainage of the upper urinary tract over fistulas or ureteral obstacles (e.g.: periureteral tumor); Healing of the ureter.
GUDID distribution status
Not in Commercial Distribution
Size
Length — 30 Centimeter
Catheter Gauge — 7 French

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
03600040927052
GUDID
03600040197929
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No