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Retractor A.4081

by Sapi Med SpA

Part of a family of 42 devices: see the family page

Ref A.4081LModel Proctoscope

Retractor A.4081 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 15 Sep 2025 (Basic UDI-DI 803363880ANSCPB6), cleared under FDA 510(k) K070913 on 10 Aug 2007 and listed in FDA GUDID since 25 Nov 2016 (UDI-DI 08033638800089), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

1 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K070913

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/MDR EUDAMED Number803363880ANSCPB6 Basic UDI-DI 08033638800089UDI-DIDate15 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08033638800089 UDI-DI Date25 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK070913 Date10 Aug 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803363880ANSCPB6 registered 15 Sep 2025 Active
  • FDA 510(k) K070913 decided 10 Aug 2007 Active
  • FDA GUDID UDI-DI 08033638800089 listed 25 Nov 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

1 recall · FDA

    • Terminated Z-1901-2021 FDA Class II initiated 23 Apr 2021 on shared 510(k) K070913

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K070913
  2. Listed FDA GUDID 08033638800089
  3. Recall initiated FDA recalls Z-1901-2021
  4. Registered EUDAMED 803363880ANSCPB6

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Trunk-End Anal Retractor + LED Light EUDAMED
Retractor GUDID
Generic name
Optical anoscope, single-use
Model / Ref / Catalog
Proctoscope EUDAMED
A.4081L EUDAMED
A.4081 GUDID
Primary DI / UDI-DI
08033638800089
Basic UDI-DI
803363880ANSCPB6
510(k) Number
FDA product code
FER
EMDN code
G02060301 Anoscopes
GMDN term
Optical anoscope, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Proctoscope
A.4081L
GUDID
A.4081
Device classEUDAMED
Class I
GUDID
Class II

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 anoscope, single-use

Cleared under the same submission (K070913)

Similar devices in this category

Other devices filed under ANOSCOPES.

Other devices from Sapi Med SpA

See all devices from Sapi Med SpA →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)