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Disposable Emr Kit K-005

by Olympus Medical Systems Corporation

Ref N1070830

Disposable Emr Kit K-005 is a device classified as Class IIb in the EU and Class II in the US made by Olympus Medical Systems Corporation, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI B-04953170137426) and listed in FDA GUDID since 21 Sep 2018 (UDI-DI 04953170137426), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170137426 Basic UDI-DI 04953170137426UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170137426 UDI-DI Date21 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04953170137426 registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 04953170137426 listed 21 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04953170137426
  2. Registered EUDAMED B-04953170137426

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  • Withdrawn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
Disposable Emr Kit K-005 EUDAMED
Disposable Emr Kit GUDID
Generic name
Endoscopic electrosurgical submucosal lift/resection set
Model / reference
N1070830 EUDAMED
K-005 GUDID
Primary DI / UDI-DI
04953170137426
Basic UDI-DI
B-04953170137426
FDA product code
FDS
EMDN code
G03030102 Polypectomy snares, non-revolving
GMDN term
Endoscopic electrosurgical submucosal lift/resection set
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
N1070830
GUDID
K-005
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Endoscopic electrosurgical submucosal lift/resection set

Similar devices in this category

Other devices filed under POLYPECTOMY SNARES, NON-REVOLVING.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)