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Fenom Flo™ 701098-001

by Medical Graphics Corp.

Ref 701098-001

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00810016252283 UDI-DI Date10 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number081001625701098-001PK Basic UDI-DI 00810016252283UDI-DIDate27 Mar 2026RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
Fenom Flo EUDAMED
Fenom Flo™ GUDID
Generic Name
Nitrogen monoxide analyser
Model / Ref / Catalog
701098-001, 800861-001
Primary DI / UDI-DI
00810016252283
Basic UDI-DI
081001625701098-001PK
Direct Marketing DI
00810016252283
510(k) Number
FDA Product Code
MXA
EMDN Code
W02079099 Various general purpose IVD instruments - other
GMDN Term
Nitrogen monoxide analyser
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.3080
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class II

Related devices

Cleared under the same submission (K251674)

Other devices from Medical Graphics Corp.

See all devices from Medical Graphics Corp. →

Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
  • New Device
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (17)

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