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Rectoscope A.4522

by Sapi Med SpA

Part of a family of 7 devices: see the family page

Ref A.4522Model Proctoscope, MPR

Rectoscope A.4522 is a device classified as Class I in the EU and Class II in the US made by Sapi Med SpA, registered in EUDAMED on 13 Mar 2026 (Basic UDI-DI 803363880RCTSCSTVX), cleared under FDA 510(k) K070915 on 6 Jul 2007 and listed in FDA GUDID since 25 Nov 2016 (UDI-DI 08033638800263), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K070915

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number803363880RCTSCSTVX Basic UDI-DI 08033638800263UDI-DIDate13 Mar 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number803363880RCTSCSTVX Basic UDI-DI 08033638800263UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033638800263 UDI-DI Date25 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK070915 Date6 Jul 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803363880RCTSCSTVX registered 13 Mar 2026 Active· +1 more in the status table
  • FDA 510(k) K070915 decided 6 Jul 2007 Active
  • FDA GUDID UDI-DI 08033638800263 listed 25 Nov 2016 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K070915
  2. Listed FDA GUDID 08033638800263
  3. Recall initiated FDA recalls Z-1901-2021
  4. Registered EUDAMED 803363880RCTSCSTVX

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
MPR - Multi Purpose Rectoscope EUDAMED
Mpr EUDAMED
Rectoscope GUDID
Generic name
Optical proctoscope, single-use
Device name
Proctoscope
Model / Ref / Catalog
A.4522, Proctoscope, MPR
Primary DI / UDI-DI
08033638800263
Basic UDI-DI
803363880RCTSCSTVX, B-08033638800263
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
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08033638800263: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Optical proctoscope, single-use

Cleared under the same submission (K070915)

Similar devices in this category

Other devices filed under ANOSCOPES.

Other devices from Sapi Med SpA

See all devices from Sapi Med SpA →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)