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LiNA PowerBlade

by LiNA Medical AG Switzerland EUDAMEDGUDID

Ref 5010-E-160Model 5005-E, 5005-E-160, 5005-E-C, 5005-E-C-160; 5010-E, 5010-E-160, 5005-Y, 5005-Y-160, 5005-Y-C, 5005-Y-C-160, 5010-Y, 5010-Y-160

Product code GEIEMDN K020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05708265015832 UDI-DIDate3 Apr 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number57082651018-126 Basic UDI-DIDate24 Feb 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Model / Reference
5005-E, 5005-E-160, 5005-E-C, 5005-E-C-160, 5010-E, 5010-E-160, 5005-Y, 5005-Y-160, 5005-Y-C, 5005-Y-C-160, 5010-Y, 5010-Y-160
Primary DI / UDI-DI
05708265015832
Basic UDI-DI
57082651018-126
FDA Product Code
GEI
EMDN Code
K020199 Mono- and bipolar devices, single use - other
GMDN Term
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
Market of Registration
Denmark
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000046832
Authorised representative
LiNA Medical Polska Sp. z o.o. PL-AR-000039364

Other devices from LiNA Medical AG

See all devices from LiNA Medical AG →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • 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

Sources (2)

  • EUDAMED 6178931b-2801-4ebe-82e6-2c6adfbf021c 61 fields · synced 22 Oct 2026
  • FDA UDI 6ece7bfb-3931-45c3-b94b-fa46d66f55bc 33 fields · synced 22 Oct 2026