Skip to content

Pladuo, Plasmaduo

by SHENB Co., Ltd.

Ref Plasma Surgical UnitModel PLADUO, PLASMADUO

Pladuo, Plasmaduo (Plasma Surgical Unit) is a nitrogen plasma skin surface treatment system (EU MDR Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by shenb Co., Ltd., registered in EUDAMED on 16 Aug 2024 (Basic UDI-DI 88000171SH007CG), cleared under FDA 510(k) K232223 on 24 Oct 2023 and listed in FDA GUDID since 1 Nov 2023 (UDI-DI 08800017101118), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232223

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000171SH007CG Basic UDI-DI 08800017101118UDI-DIDate16 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800017101118 UDI-DI Date1 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232223 Date24 Oct 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000171SH007CG registered 16 Aug 2024 Active
  • FDA 510(k) K232223 decided 24 Oct 2023 Active
  • FDA GUDID UDI-DI 08800017101118 listed 1 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K232223
  2. Listed FDA GUDID 08800017101118
  3. Registered EUDAMED 88000171SH007CG

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Pladuo, Plasmaduo EUDAMED
PlaDuo System GUDID
Generic name
Nitrogen plasma skin surface treatment system
Model / reference
PLADUO, PLASMADUO, Plasma Surgical Unit
Primary DI / UDI-DI
08800017101118
Basic UDI-DI
88000171SH007CG
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Nitrogen plasma skin surface treatment system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PLADUO, PLASMADUO
Plasma Surgical Unit
GUDID
PlaDuo
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.

Manufacturer details

EUDAMED SRN
KR-MF-000021619
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Foot-switch, electrical

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from shenb Co., Ltd.

See all devices from shenb Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)