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C2 Cryoablation(TM) System catheter

by Pentax Medical a Division of Pentax of America Inc 6 variants

Ref FG-1030Model FG-1027

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 Number4961333020017XZ Basic UDI-DI 00854924006309UDI-DIDate2 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00854924006309 UDI-DI Date8 Mar 2018ListedStatusListed 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  • Withdrawn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
C2 Cryoablation(TM) System catheter EUDAMED
C2 CryoBalloon GUDID
Generic Name
General cryosurgical system, cryogen gas, mechanical
Device Name
C2 Cryoballoon (TM) System Catheter
Model / Ref / Catalog
FG-1027, FG-1030
Primary DI / UDI-DI
00854924006309
Basic UDI-DI
4961333020017XZ
FDA Product Code
GEH
EMDN Code
G0301010101 Oesophageal balloon catheters, low pressure
GMDN Term
General cryosurgical system, cryogen gas, mechanical
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4350
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000042816
Authorised representative
PENTAX Europe GmbH DE-AR-000000006

Other devices from Pentax Medical a Division of Pentax of America Inc

See all devices from Pentax Medical a Division of Pentax of America Inc →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No