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Electroconductive gel for ECG/EEG/EMG diagnostics, red color. "ZERO GEL". 260 gram

by Tvel Limited Liability Company EUDAMED

Active European Union

Ref ZG260, ZG250, ZG500, ZG40, ZGS5000 maxp, ZGS5000 stp

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number482025532ECGEEGGELT9 Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Trade Name
Electroconductive gel for ECG/EEG/EMG diagnostics, red color. "ZERO GEL". 260 gram
Electroconductive gel for ECG/EEG/EMG diagnostics, red color. "ZERO GEL". 250 gram
Electroconductive gel for ECG/EEG/EMG diagnostics, red color. "ZERO GEL". 500 gram
Electroconductive gel for ECG/EEG/EMG diagnostics, red color. "ZERO GEL". 40 gram
Electroconductive gel for ECG/EEG/EMG diagnostics, red color. "ZERO GEL". Packaging: bag, "maximum". 5000 gram
Electroconductive gel for ECG/EEG/EMG diagnostics, red color. "ZERO GEL". Packaging: bag, "standard". 5000 gram
Device Name
Electroconductive gel for ECG/EEG/EMG diagnostics
Model / Reference
ZG260, ZG250, ZG500, ZG40, ZGS5000 maxp, ZGS5000 stp
Primary DI / UDI-DI
04820255320281, 04820255320083, 04820255320090, 04820255320137, 04820255320113, 04820255320120
Basic UDI-DI
482025532ECGEEGGELT9
EMDN Code
Z1399 Non-specific consumables for diagnostic instruments - other
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
UA-MF-000050923
Authorised representative
Przedsiębiorstwo Innowacyjno-Handlowe "VARIA" Sp. z o. o. PL-AR-000043714

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Properties

Other properties (13)

  • Sterile: No
  • 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