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Proctoscope

by SAPI MED S.p.A. Italy EUDAMEDGUDID

Ref A.4520LINSModel Proctoscope Product code KDMEMDN G02060301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803363880RCTSCFF Basic UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033638801536 UDI-DIDate17 Feb 2025ListedStatusIn distribution

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

Certificates: none listed in EUDAMED

Recalls

1 recall · FDA

    • Terminated Z-1901-2021 FDA Class II initiated 23 Apr 2021

    Due to issue with product sterility. Sterilization service provider had falsified records.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Proctoscope EUDAMED
Rectoscope equipment GUDID
Generic Name
Optical proctoscope, single-use
Model / Ref / Catalog
Proctoscope, A.4520LINS, Rectoscope equipment with LED and insufflator
Primary DI / UDI-DI
08033638801536
Basic UDI-DI
803363880RCTSCFF
510(k) Number
FDA Product Code
KDM
EMDN Code
G02060301 Anoscopes
GMDN Term
Optical proctoscope, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1500
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Proctoscope
A.4520LINS
GUDID
Rectoscope equipment with LED and insufflator
Device ClassEUDAMED
Class I
GUDID
Class II
Contains LatexEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IT-MF-000023733

Other devices from SAPI MED S.p.A.

See all devices from SAPI MED S.p.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • Sterile: No
  • Implantable: No
  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No

Sources (2)

  • EUDAMED 0c8551ca-952a-4343-a8e3-26e959c9c64f 61 fields · synced 22 Oct 2026
  • FDA UDI afdb3b8b-2a9a-4054-a90b-2734800e3f4e 35 fields · synced 30 May 2026