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BioShield 00711137

by US Endoscopy

Ref 00711137Model Biopsy Valve Non-Sterile

BioShield 00711137 is an endoscope working-channel valve (EU MDR Class I; FDA Class II) made by US Endoscopy, registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI 0724995ENBSHLDIRRIGNS2C), cleared under FDA 510(k) K232951 on 20 Oct 2023 (2 earlier submissions) and listed in FDA GUDID since 19 Mar 2020 (UDI-DI 00724995183592), active as of 25 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) K232951

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995ENBSHLDIRRIGNS2C Basic UDI-DI 00724995183592UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK232951 Date20 Oct 2023DecidedStatusActive
United StatesGUDID listing GUDID Number00724995183592 UDI-DI Date19 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0724995ENBSHLDIRRIGNS2C registered 8 Oct 2026 Active
  • FDA 510(k) K232951 decided 20 Oct 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00724995183592 listed 19 Mar 2020 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-0861-2015 FDA Class II initiated 31 Oct 2014 on shared 510(k) K070420

    Packaging non-conformance related to the integrity of the sterile pouch seal.

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

Timeline

6 dated events

  1. Cleared FDA 510(k) K070420
  2. Recall initiated FDA recalls Z-0861-2015
  3. Listed FDA GUDID 00724995183592
  4. Cleared FDA 510(k) K210342
  5. Cleared FDA 510(k) K232951
  6. Registered EUDAMED 0724995ENBSHLDIRRIGNS2C

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
BioShield
Generic name
Endoscope working-channel valve, single-use
Device name
Biopsy Valve Non-Sterile
Model / Ref / Catalog
00711137, Biopsy Valve Non-Sterile
Primary DI / UDI-DI
00724995183592
Basic UDI-DI
0724995ENBSHLDIRRIGNS2C
510(k) Number
FDA product code
ODD, OCX, ODC
EMDN code
G0380 Digestive endoscopy devices - accessories
GMDN term
Endoscope working-channel valve, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Endoscope working-channel valve, single-use

Cleared under the same submission (K070420)

and 6 more cleared under K070420

Cleared under the same submission (K210342)

and 6 more cleared under K210342

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES.

Other devices from US Endoscopy

See all devices from US Endoscopy →

Properties

  • Single use
  • Contains endocrine-disrupting substances
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)