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PerformancePlus™ A10005

by Graphic Controls Acquisition Corp

Ref A10005NB

PerformancePlus™ A10005 is a device classified as Class I in the EU and Class II in the US made by Graphic Controls Acquisition Corp, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 009336Elec-SnapFV), cleared under FDA 510(k) K021537 on 3 Mar 2003 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 10813150020227), active as of 24 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 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K021537

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number009336Elec-SnapFV Basic UDI-DI 10813150020227UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10813150020227 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK021537 Date3 Mar 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 009336Elec-SnapFV registered 10 Sep 2026 Active
  • FDA 510(k) K021537 decided 3 Mar 2003 Active
  • FDA GUDID UDI-DI 10813150020227 listed 16 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K021537
  2. Listed FDA GUDID 10813150020227
  3. Registered EUDAMED 009336Elec-SnapFV

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  • Withdrawn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
Nissha Medical Technologies EUDAMED
PerformancePlus™ GUDID
Generic name
Electrocardiographic electrode, single-use
Device name
Nissha Medical Technologies ECG electrodes
Model / Ref / Catalog
A10005NB EUDAMED
A10005 GUDID
Primary DI / UDI-DI
10813150020227
Basic UDI-DI
009336Elec-SnapFV
510(k) Number
FDA product code
GXY, DRX
EMDN code
C020501 ECG electrodes
GMDN term
Electrocardiographic electrode, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320, 870.2360
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
A10005NB
GUDID
A10005
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Electrocardiographic electrode, single-use

Cleared under the same submission (K021537)

Similar devices in this category

Other devices filed under ECG ELECTRODES.

Other devices from Graphic Controls Acquisition Corp

See all devices from Graphic Controls Acquisition Corp →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)