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BougieCap P

by Ovesco Endoscopy AG

Part of a family of 8 devices: see the family page

Ref 400.40Model BougieCap

BougieCap P (400.40) is a device classified as Class I in the EU and Class II in the US made by Ovesco Endoscopy AG, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 426020631REMV00458) with CE/MDR certificate 1000317372 valid until 16 Nov 2030 and listed in FDA GUDID since 16 Jan 2026 (UDI-DI 04260206311966), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

16 Nov 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000317372 Date25 Sep 2026IssuedStatusActive expires 16 Nov 2030
United StatesGUDID listing GUDID Number04260206311966 UDI-DI Date16 Jan 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426020631REMV00458 registered 17 Sep 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04260206311966 listed 16 Jan 2026 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000317372 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    25 Sep 2026
    Expires
    16 Nov 2030
    Reason
    Change approved

Timeline

4 dated events

  1. Listed FDA GUDID 04260206311966
  2. Registered EUDAMED 426020631REMV00458
  3. Certificate issued EUDAMED 1000317372
  4. Certificate expires EUDAMED 1000317372

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Endoscopic gastrointestinal stenosis dilator
Model / Ref / Catalog
BougieCap, 400.40, P
Primary DI / UDI-DI
04260206311966
Basic UDI-DI
426020631REMV00458
FDA product code
KNQ
EMDN code
G010101 Oesophageal bougies
GMDN term
Endoscopic gastrointestinal stenosis dilator
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.5365
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 26.9 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BougieCap
400.40
GUDID
P
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.

Similar devices in this category

Other devices filed under OESOPHAGEAL BOUGIES.

Other devices from Ovesco Endoscopy AG

See all devices from Ovesco Endoscopy AG →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)