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SCANLAN® MicroSurgical Instruments 3784-40

by Scanlan International Inc

Ref 3003-191

SCANLAN® MicroSurgical Instruments 3784-40 is a Class I device made by Scanlan International Inc, registered in EUDAMED on 18 May 2026 (Basic UDI-DI B-00846159032697) and listed in FDA GUDID since 6 Feb 2020 (UDI-DI 00846159032697), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00846159032697 Basic UDI-DI Date18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846159032697 UDI-DI Date6 Feb 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00846159032697 registered 18 May 2026 Active
  • FDA GUDID UDI-DI 00846159032697 listed 6 Feb 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846159032697
  2. Registered EUDAMED B-00846159032697

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  • Withdrawn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® MicroSurgical Instruments
SCANLAN® Needle Holders
Generic name
Open-surgery dissector
Suturing needle holder, reusable
Device name
SCANLAN® Yasargil Micro Raspatory
SCANLAN® Jacobson Micro Needle Holder
Model / Ref / Catalog
3003-191, 3784-40
Primary DI / UDI-DI
00846159032697, 00846159002911
Basic UDI-DI
B-00846159032697, B-00846159002911
FDA product code
GZX, FHQ
EMDN code
L031102, L0205
GMDN term
Open-surgery dissector
Suturing needle holder, reusable
Device class
Class I
Regulation number
882.4525, 876.4730
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)