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SCANLAN® Retractor 8008-218

by Scanlan International Inc

Ref 8008-218

SCANLAN® Retractor 8008-218 is a Class I device made by Scanlan International Inc, registered in EUDAMED on 18 May 2026 (Basic UDI-DI B-00846159021042) and listed in FDA GUDID since 5 Aug 2016 (UDI-DI 00846159021042), 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-00846159021042 Basic UDI-DI 00846159021042UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846159021042 UDI-DI Date5 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00846159021042 registered 18 May 2026 Active
  • FDA GUDID UDI-DI 00846159021042 listed 5 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846159021042
  2. Registered EUDAMED B-00846159021042

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  • Withdrawn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® Retractor
Generic name
Self-retaining surgical retractor, reusable
Device name
SCANLAN® Bailey Pediatric Retractor
Model / Ref / Catalog
8008-218
Primary DI / UDI-DI
00846159021042
Basic UDI-DI
B-00846159021042
FDA product code
GAD
EMDN code
L03140199 Spreaders and retractors for general surgery, reusable - other
GMDN term
Self-retaining surgical retractor, reusable
Device class
Class I
Regulation number
878.4800
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

Related devices

Category: Self-retaining surgical retractor, reusable

Similar devices in this category

Other devices filed under SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER.

Other devices from Scanlan International Inc

See all devices from Scanlan International Inc →

Properties

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