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Kolibri RJA108

by Coloplast A/S

Ref RJA108

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

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089326358528K Basic UDI-DI Date23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03600040257609 UDI-DI Date20 Jan 2023ListedStatusListed 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.

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  • Withdrawn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
Kolibri
Generic Name
Urological surgical procedure kit, non-medicated, single-use
Device Name
Vortek percutaneous nephrostomy kit with J catheter
Model / Ref / Catalog
RJA108
Primary DI / UDI-DI
03600040257609 EUDAMED
03600040954300 EUDAMED
05701780271486 GUDID
Basic UDI-DI
57089326358528K
FDA Product Code
LJE
EMDN Code
U040202 Nephrostomy kits, seldinger method
GMDN Term
Urological surgical procedure kit, non-medicated, single-use
Device Class
Class IIb EUDAMED
U GUDID
Medical Purpose
Short-term percutaneous drainage of the upper urinary tract.
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Catheter Gauge — 8 French

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
03600040257609
03600040954300
GUDID
05701780271486
Device ClassEUDAMED
Class IIb
GUDID
U

Related devices

Category: Urological surgical procedure kit, non-medicated, single-use

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

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

Other properties (8)

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