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Swann-Morton Limited

by Swann-Morton Ltd EUDAMEDGUDID

Active European Union and United States

Ref P626 - Paragon Sterile Disposable Scalpel With Retracting Guard Stitch CutterModel 39 / 49 / 36 / P6 Codes

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05033955106263 UDI-DIDate15 Oct 2024ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number50339550STERILEEORETSCQ3 Basic UDI-DIDate9 Oct 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
Swann-Morton Limited EUDAMED
Swann Morton Ltd. GUDID
Generic Name
Scalpel, single-use
Device Name
Sterile EO Retractable Stitch Cutters
Model / Ref / Catalog
39 / 49 / 36 / P6 Codes EUDAMED
P626 - Paragon Sterile Disposable Scalpel With Retracting Guard Stitch Cutter EUDAMED
PARAGON STITCH CUTTER STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD GUDID
P626 GUDID
Primary DI / UDI-DI
05033955106263
Basic UDI-DI
50339550STERILEEORETSCQ3
Unit of Use DI
05063043106264
FDA Product Code
FZT
EMDN Code
V0102 Staple remover knives, single-use
GMDN Term
Scalpel, single-use
Device Class
Class I
Regulation Number
878.4800
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
39 / 49 / 36 / P6 Codes
P626 - Paragon Sterile Disposable Scalpel With Retracting Guard Stitch Cutter
GUDID
PARAGON STITCH CUTTER STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD

Manufacturer details

EUDAMED SRN
GB-MF-000001890
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Swann-Morton Ltd

See all devices from Swann-Morton Ltd →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No