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Gemini Compact Microplate Processor

by Stratec Se

Ref 10041566

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

CE IVDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number42606786862804M Basic UDI-DI 04260678680010UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260678680010 UDI-DI Date5 Sep 2025ListedStatusListed 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  • Withdrawn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/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Gemini Compact Microplate Processor EUDAMED
Gemini GUDID
Generic Name
Enzyme immunoassay (EIA) analyser IVD
Model / Ref / Catalog
10041566, Compact Microplate Processor
Primary DI / UDI-DI
04260678680010
Basic UDI-DI
42606786862804M
FDA Product Code
JJE
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN Term
Enzyme immunoassay (EIA) analyser IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2160
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
10041566
GUDID
Compact Microplate Processor
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000007261

Other devices from Stratec Se

Properties

  • Surgical Instrument
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No