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Smartfreeze™

by Boston Scientific Corporation United States EUDAMEDGUDID

Ref M004CRBS6500

Product code OAEEMDN C020380

Regulatory status

as of 24 Oct 2026

Recall ongoing. 7 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000237MZ Basic UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00191506007737 UDI-DIDate21 Aug 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

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.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Cardiac cryosurgical system remote control
Device Name
SMARTFREEZE Cryo-Console
Model / Ref / Catalog
M004CRBS6500
Primary DI / UDI-DI
00191506007737
Basic UDI-DI
01915060000000000000237MZ
PMA Number
FDA Product Code
OAE
EMDN Code
C020380 Ablation of arrhythmogenic focus devices - accessories
GMDN Term
Cardiac cryosurgical system remote control
Device Class
Class IIb EUDAMED
Class III GUDID
Market of Registration
Netherlands
Commercial Distribution
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 500ea698-e49a-48ad-b3b7-642fe4cfd079 61 fields · synced 22 Oct 2026
  • FDA UDI 23c0763d-62eb-4d0f-9762-2b19138b4d44 35 fields · synced 30 May 2026