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SCANLAN® Dilators 9009-54

by Scanlan International Inc

Ref 3003-402

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

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00846159010589 Basic UDI-DI Date18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846159010589 UDI-DI Date4 May 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.

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  • Withdrawn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
SCANLAN® Dilators
SCANLAN® Needle Holders
Generic Name
Vascular dilator, reusable
Suturing needle holder, reusable
Device Name
SCANLAN® Garrett Vascular Dilators
SCANLAN® Mayo‑Hegar Needle Holder
Model / Ref / Catalog
3003-402, 9009-54
Primary DI / UDI-DI
00846159010589, 00846159003185
Basic UDI-DI
B-00846159010589, B-00846159003185
FDA Product Code
DWP, FHQ
EMDN Code
L031102, L0205
GMDN Term
Vascular dilator, reusable
Suturing needle holder, reusable
Device Class
Class I EUDAMEDGUDID
Class II GUDID
Regulation Number
870.4475, 876.4730
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class I
Class II

Related devices

Category: Vascular dilator, reusable

Other devices from Scanlan International Inc

See all devices from Scanlan International Inc →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • 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
  • Expiration Date: No
  • Manufacturing Date: No