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Solventum™ 2346N

by Solventum US LLC

Ref 2346N

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, self-declared

Class I: no certifier involved

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
European UnionCE/MDR EUDAMED Number01979988401010000000072MU Basic UDI-DI 00197998355387UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00197998355387 UDI-DI Date15 Feb 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Solventum™
Generic Name
Electrode conductive medium
Device Name
Solventum™ Defib-Pads
Model / Ref / Catalog
2346N
Primary DI / UDI-DI
00197998355387 EUDAMED
00197998355400 GUDID
Basic UDI-DI
01979988401010000000072MU
FDA Product Code
GYB
EMDN Code
C020401 External cardioversion defibrillator electrode pads
GMDN Term
Electrode conductive medium
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1275
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00197998355387
GUDID
00197998355400
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Solventum US LLC

See all devices from Solventum US LLC →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No