Skip to content

i.Series

by Helmer Scientific

Ref iLR125-GXCModel i.Series

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081639402TFR0116M Basic UDI-DI 00816394022067UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816394022067 UDI-DI Date13 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
i.Series EUDAMED
Helmer Scientific GUDID
Generic Name
Laboratory refrigerator, basic
Device Name
Refrigerator
Model / Reference
i.Series, iLR125-GXC
Primary DI / UDI-DI
00816394022067
Basic UDI-DI
081639402TFR0116M
Direct Marketing DI
00816394022067
FDA Product Code
LXG
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Laboratory refrigerator, basic
Device Class
Class I
Regulation Number
862.2050
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

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

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No