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Coloplast AE0A35

by Coloplast A/S

Ref AE0A35

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089326358458N Basic UDI-DI 03600040926499UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03600040926499 UDI-DI Date5 Apr 2024ListedStatusListed 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  • Withdrawn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
Coloplast
Generic Name
Gastro-urological guidewire, single-use
Device Name
Stainless steel PTFE coated guidewire
Model / Ref / Catalog
AE0A35
Primary DI / UDI-DI
03600040926499
Basic UDI-DI
57089326358458N
FDA Product Code
OCY
EMDN Code
U0602 Urological guidewires, not hydrophilic
GMDN Term
Gastro-urological guidewire, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Outer Diameter — 0.035 Inch
Length — 150 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Gastro-urological guidewire, single-use

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

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

Other properties (18)

  • 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
  • Serial Number: No
  • Manufacturing Date: No