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SCANLAN® Retractor Crank Handle

by Scanlan International Inc. EUDAMEDGUDID

Active European Union

Ref 109-A2

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00846159040159 Basic UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846159040159 UDI-DIDate29 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
SCANLAN® Retractor
Generic Name
Self-retaining surgical retractor, reusable
Device Name
SCANLAN® Retractor Crank Handle
Model / Ref / Catalog
109-A2
Primary DI / UDI-DI
00846159040159
Basic UDI-DI
B-00846159040159
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
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000010251
Authorised representative
MedEnvoy Global BV NL-AR-000024028

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