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Proctoscope

by SAPI MED S.p.A. EUDAMEDGUDID

Active European Union and United States

Ref A.4125, A.4300, A.4200V, A.4522LINS, A.4023M, A.4131.1, A.4300LR, A.4522LI, A.4513I, A.4513LINSModel Proctoscope, MPR, Set Proctoscope

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803363880RCTSCFF Basic UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033638800201 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

Trade Name
Proctoscope EUDAMED
Mpr EUDAMED
Set Proctoscope EUDAMED
Rectoscope equipment GUDID
Rectoscope GUDID
Generic Name
Optical proctoscope, single-use
Model / Ref / Catalog
Proctoscope, A.4125, A.4300, A.4200V, A.4522LINS, A.4023M, A.4131.1, A.4300LR, A.4522LI, A.4513I, A.4513LINS, MPR, Set Proctoscope, Rectoscope equipment with LED and insufflator
Primary DI / UDI-DI
08033638800201, 08033638802144, 08033638802137, 08033638800676, 08033638803394, 08033638801512, 08033638803431, 08033638803783, 08033638800614, 08033638801291
510(k) Number
FDA Product Code
KDM
GMDN Term
Optical proctoscope, single-use
Regulation Number
876.1500
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
No
Yes
GUDID
No
Contains LatexEUDAMED
No
GUDID
No
Yes

Manufacturer details

EUDAMED SRN
IT-MF-000023733

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