Isolator Synergy™
Ref OLL2/A000362-9Model OLL2/OSL2/EMR2/EML2/EMT/OSH/OLH
Isolator Synergy™ (OLL2/A000362-9) is a Class III device made by Atricure, Inc., registered in EUDAMED on 13 Jul 2026 (Basic UDI-DI 08401439000000000000014ZL), active as of 7 Nov 2026.
Active
CE MDR
Valid until
12 Aug 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08401439000000000000014ZL 10840143910746 | Date13 Jul 2026 | StatusActive |
Official records
- EUDAMED public site 08401439000000000000014ZL
Certificates
- MDR 752521 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 30 Jul 2026
- Expires
- 12 Aug 2029
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- OLL2/OSL2/EMR2/EML2/EMT/OSH/OLH, OLL2/A000362-9
- Primary DI / UDI-DI
- 10840143910746
- Basic UDI-DI
- 08401439000000000000014ZL
- EMDN code
- C020399 Cardiac tissue ablation devices - other
- 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
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