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Olympus ARV110

by KeyMed (Medical and Industrial Equipment) Ltd

Ref K10037616Model ENDOCUFF VISION

Olympus ARV110 (K10037616) is a device classified as Class I in the EU and Class II in the US made by KeyMed (Medical and Industrial Equipment) Ltd, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 5019778MF011QZ) and listed in FDA GUDID since 30 Oct 2023 (UDI-DI 15019778008653), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5019778MF011QZ Basic UDI-DI 15019778008653UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15019778008653 UDI-DI Date30 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5019778MF011QZ registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 15019778008653 listed 30 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 15019778008653
  2. Registered EUDAMED 5019778MF011QZ

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  • Withdrawn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

Trade name
Endocuff Vision ARV110 EUDAMED
Olympus GUDID
Generic name
Endoscope distal observation spacer, single-use
Model / Ref / Catalog
ENDOCUFF VISION, K10037616, ARV110
Primary DI / UDI-DI
15019778008653
Basic UDI-DI
5019778MF011QZ
FDA product code
FED
EMDN code
G0380 Digestive endoscopy devices - accessories
GMDN term
Endoscope distal observation spacer, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ENDOCUFF VISION
K10037616
GUDID
ARV110
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 distal observation spacer, single-use

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES.

Other devices from KeyMed (Medical and Industrial Equipment) Ltd

See all devices from KeyMed (Medical and Industrial Equipment) Ltd →

Properties

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