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ImmunoFLOW Mycoplasma IgM Control

by GenDx LLC

Ref 3925Model ImmunoFLOW

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

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00613745000091 Basic UDI-DI 00613745000091UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00613745000091 UDI-DI Date19 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
ImmunoFLOW Mycoplasma IgM Control EUDAMED
ImmunoFLOW Mycoplasma IgM Positive Control GUDID
Generic Name
Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device Name
ImmunoFLOW MYCOPLASMA Positive Control
Model / Ref / Catalog
ImmunoFLOW, 3925, 800-3925
Primary DI / UDI-DI
00613745000091
Basic UDI-DI
B-00613745000091
EMDN Code
W0105010802 Mycoplasma antibody assays
GMDN Term
Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device Class
Class IVD General
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ImmunoFLOW
3925
GUDID
800-3925

Manufacturer details

EUDAMED SRN
US-MF-000052622
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Properties

  • Single Use
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No