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Smartfreeze™

by Boston Scientific Corporation 3 variants

Ref M004CRBS4000

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

7 ongoing

This device is named in the recall

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 Number01915060000000000000297NK Basic UDI-DI 08714729992691UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729992691 UDI-DI Date21 Aug 2023ListedStatusListed 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.

Recalls

7 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-0298-2025 FDA Class I initiated 10 Oct 2024
    • Ongoing Z-0302-2025 FDA Class I initiated 10 Oct 2024
    • Ongoing Z-0301-2025 FDA Class I initiated 10 Oct 2024
    • Ongoing Z-0299-2025 FDA Class I initiated 10 Oct 2024
    • Ongoing Z-0303-2025 FDA Class I initiated 10 Oct 2024
    • Ongoing Z-0300-2025 FDA Class I initiated 10 Oct 2024
    • Ongoing Z-0297-2025 FDA Class I initiated 10 Oct 2024

    Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

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  • Withdrawn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

Generic Name
Cardiac cryosurgical system
Device Name
Smartfreeze Cryo-Console
Model / Ref / Catalog
M004CRBS4000
Primary DI / UDI-DI
08714729992691
Basic UDI-DI
01915060000000000000297NK
PMA Number
FDA Product Code
OAE
EMDN Code
C020399 Cardiac tissue ablation devices - other
GMDN Term
Cardiac cryosurgical system
Device Class
Class IIb EUDAMED
Class III GUDID
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class III

Manufacturer details

EUDAMED SRN
US-MF-000004702
Authorised representative
Boston Scientific Limited IE-AR-000003840

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No