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i.Series

by Helmer Scientific 4 variants

Ref iLR256-GXCModel i.Series

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081639402TFR0116M Basic UDI-DI 00816394022449UDI-DIDate24 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Refrigerator
Model / Reference
i.Series, iLR256-GXC
Primary DI / UDI-DI
00816394022449
Basic UDI-DI
081639402TFR0116M
Direct Marketing DI
00816394022449
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000003326
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Helmer Scientific

See all devices from Helmer Scientific →

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