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S-49 Electrode

by Jeisys Medical Inc.

Ref S-49Model S-49 TIP

S-49 Electrode is an electrosurgical system (EU MDD Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Jeisys Medical Inc., registered in EUDAMED on 12 Mar 2026 (Basic UDI-DI B-08800020107473), cleared under FDA 510(k) K192545 on 20 Feb 2020 and listed in FDA GUDID since 27 Feb 2020 (UDI-DI 08800020107473), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192545

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800020107473 Basic UDI-DI 08800020107473UDI-DIDate12 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800020107473 UDI-DI Date27 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192545 Date20 Feb 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800020107473 registered 12 Mar 2026 Active
  • FDA 510(k) K192545 decided 20 Feb 2020 Active
  • FDA GUDID UDI-DI 08800020107473 listed 27 Feb 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192545
  2. Listed FDA GUDID 08800020107473
  3. Registered EUDAMED B-08800020107473

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
S-49 Electrode EUDAMED
POTENZA Tip GUDID
Generic name
Electrosurgical system
Model / reference
S-49 TIP, S-49
Primary DI / UDI-DI
08800020107473 EUDAMED
08800020111111 GUDID
Basic UDI-DI
B-08800020107473
510(k) Number
FDA product code
GEI
EMDN code
K020380 Devices for surgery with radiofrequency generator, single-use - accessories
GMDN term
Electrosurgical system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08800020107473
GUDID
08800020111111
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08800020107473; FDA GUDID lists 08800020111111), so their flags are not compared. 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.

Manufacturer details

EUDAMED SRN
KR-MF-000008513
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Radio-frequency ablation system

Similar devices in this category

Other devices filed under DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES.

Other devices from Jeisys Medical Inc.

See all devices from Jeisys Medical Inc. →

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)