cryoICE® System
Ref A001361Model CMF1
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08401439000000000000006ZM 30840143904725 | Date15 Jun 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- cryoICE System ACM Footswitch
- Model / Reference
- CMF1, A001361
- Primary DI / UDI-DI
- 30840143904725
- Basic UDI-DI
- 08401439000000000000006ZM
- Direct Marketing DI
- 10840143910258
- EMDN Code
- Z120102 Cryosurgery equipment
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000002974
- Authorised representative
- AtriCure Europe B.V. NL-AR-000000165
Other devices from Atricure, Inc.
Properties
Other properties (12)
- Sterile: No
- Implantable: 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