Exablate 4000 Patient Treatment Kit
Ref SET001117-SU-CEModel Exablate 4000
Active
CE MDR
Valid until
1 Feb 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7290015461Ex4000-PPTX 07290019402091 | Date26 Jul 2026 | StatusActive |
Certificates
- 3902589CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 1 Feb 2026
- Expires
- 1 Feb 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Exablate 4000 Accessories and Treatment Kits
- Model / Reference
- Exablate 4000, SET001117-SU-CE
- Primary DI / UDI-DI
- 07290019402091
- Basic UDI-DI
- 7290015461Ex4000-PPTX
- EMDN Code
- Z120610 Ultrasound therapy equipment
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- IL-MF-000011795
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Insightec Ltd
Properties
Other properties (13)
- Sterile: 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