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THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S TB-0545FCS

by Olympus Medical Systems Corporation 2 variants

Ref N5423430

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170383526 Basic UDI-DI 04953170383526UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170383526 UDI-DI Date5 Jun 2018ListedStatusListed GUDID: not 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  • Withdrawn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
THUNDERBEAT 5mm, 45 cm, Front-actuated Grip Type S TB-0545FCS EUDAMED
THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S GUDID
Generic Name
Electrosurgical handpiece, single-use
Model / Reference
N5423430 EUDAMED
TB-0545FCS GUDID
Primary DI / UDI-DI
04953170383526
Basic UDI-DI
B-04953170383526
FDA Product Code
LFL, GEI
EMDN Code
K02050109 Combined radiofrequency / ultrasonic surgery handpieces, single-use
GMDN Term
Electrosurgical handpiece, single-use
Device Class
Class IIb EUDAMED
U GUDID
Regulation Number
878.4400
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N5423430
GUDID
TB-0545FCS
Device ClassEUDAMED
Class IIb
GUDID
U

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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