cryoICE®
Ref CRYO2/A000683-14Model CRYO2/CRYO3/CRYOF
cryoICE® (CRYO2/A000683-14) is a Class III device made by Atricure, Inc., registered in EUDAMED on 29 Jun 2026 (Basic UDI-DI 08401439000000000000007ZP) with CE/MDR certificate MDR 752541 valid until 21 Aug 2027, active as of 24 Oct 2026.
Expiring
CE MDR
Valid until
21 Aug 2027
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08401439000000000000007ZP 10840143908019 | Date29 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 08401439000000000000007ZP
Certificates
- MDR 752541 Expiring
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 20 May 2026
- Expires
- 21 Aug 2027
- Reason
- Other
Timeline
- Certificate issued EUDAMED MDR 752541
- Registered EUDAMED 08401439000000000000007ZP
- Certificate expires EUDAMED MDR 752541
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Device name
- cryoablation probe
- Model / reference
- CRYO2/CRYO3/CRYOF, CRYO2/A000683-14
- Primary DI / UDI-DI
- 10840143908019
- Basic UDI-DI
- 08401439000000000000007ZP
- EMDN code
- Z120102 Cryosurgery equipment
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000002974
- Authorised representative
- AtriCure Europe B.V. NL-AR-000000165