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Camera adapter for rectoscopes

by SAPI MED S.p.A. Italy EUDAMEDGUDID

Ref A.4002, A.4200, A.4520LRINS , A.4200LR, A.4525LINS, A.4525IP , A.4525INS, A.4525, A.4525IPModel CAMERA ADAPTER FOR ANOSCOPES , Proctoscope, Set Rectoscope

Product code KDMEMDN Z12020485

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number803363880CNNTRCS Basic UDI-DIDate13 Nov 2025RegisteredStatusActive
European UnionCE/MDR EUDAMED Number803363880CNNTRCS Basic UDI-DIDate13 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08033638801970 UDI-DIDate27 Jul 2023ListedStatusIn 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDD, 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 24 Oct 2026

Trade Name
Camera adapter for rectoscopes EUDAMED
Rectoscope EUDAMED
Set Rectoscope EUDAMED
Rectoscope equipment GUDID
Generic Name
Optical proctoscope, single-use
Device Name
Proctoscope
Model / Ref / Catalog
CAMERA ADAPTER FOR ANOSCOPES, A.4002, Proctoscope, A.4200, A.4520LRINS, A.4200LR, A.4525LINS, A.4525IP, A.4525INS, A.4525, Set Rectoscope, Rectoscope equipment with insufflator, Rectoscope equipment with LED
Primary DI / UDI-DI
08033638801970, 08033638802120, 08033638801550, 08033638800713, 08033638803486, 08033638803424, 08033638800690, 08033638802274
Basic UDI-DI
803363880CNNTRCS, 803363880RCTSCFF, 803363880RCTSCSTVX, B-08033638800690, B-08033638802274
510(k) Number
FDA Product Code
KDM
EMDN Code
Z12020485, G02060301
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
CAMERA ADAPTER FOR ANOSCOPES
A.4002
Proctoscope
A.4200
A.4520LRINS
A.4200LR
A.4525LINS
A.4525IP
A.4525INS
A.4525
Set Rectoscope
GUDID
Rectoscope equipment with insufflator
Rectoscope equipment with LED
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
No
Yes
GUDID
No

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
  • Sterile NoEUDAMEDGUDIDYesEUDAMED
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (19)
  • 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
  • Premarket Exempt: No
  • Serial Number: No

Sources (12)

  • EUDAMED 5af6a3d2-81e3-4384-8228-3a4f96a511d7 61 fields · synced 22 Oct 2026
  • EUDAMED 08033638802120|803363880RCTSCFF 61 fields · synced 18 May 2026
  • FDA UDI 79d89e6f-25a9-4d88-8953-d8ca8ff02aa1 35 fields · synced 30 May 2026
  • FDA UDI 407f8cfe-541c-4ae9-b2be-2b38f5339040 35 fields · synced 30 May 2026
  • EUDAMED 08033638803486|803363880RCTSCFF 61 fields · synced 18 Jun 2026
  • EUDAMED 08033638803424|803363880RCTSCFF 61 fields · synced 15 Jul 2026
  • EUDAMED 08033638800713|803363880RCTSCFF 61 fields · synced 29 Jul 2026
  • EUDAMED 08033638800690|803363880RCTSCSTVX 61 fields · synced 31 Jul 2026
  • EUDAMED 08033638801550|803363880RCTSCFF 61 fields · synced 31 Jul 2026
  • EUDAMED 08033638802274|803363880RCTSCSTVX 61 fields · synced 2 Aug 2026
  • EUDAMED 08033638800690|B-08033638800690 61 fields · synced 24 Oct 2026
  • EUDAMED 08033638802274|B-08033638802274 61 fields · synced 24 Oct 2026