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Single Use Preloaded Sphincterotome V KD-V611M-07202A

by Olympus Medical Systems Corporation

Ref N5786530

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170403071 Basic UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170403071 UDI-DIDate5 Jan 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Single Use Preloaded Sphincterotome V KD-V611M-07202A EUDAMED
Single Use Preloaded Sphincterotome V GUDID
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device Name
Single Use Sphincterotome/ Needle knife
Model / Ref / Catalog
N5786530, KD-V611M-07202A
Primary DI / UDI-DI
04953170403071
Basic UDI-DI
B-04953170403071
FDA Product Code
KNS
EMDN Code
G03040202 Papillotomes / sphincterotomes, triple (or more) lumen
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4300
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N5786530
GUDID
KD-V611M-07202A
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No