SEERLINQ HeartCore
by Seerlinq s.r.o. Slovakia EUDAMED
Ref 1Model SEERLINQ HeartCore
EMDN Z12050892
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2025-MDR/QS-013/A | Date17 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-013/A Amended
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 17 Sep 2026
- Expires
- 7 Feb 2030
- Reason
- Mnf data change
Specification
- Model / Reference
- SEERLINQ HeartCore, 1
- Primary DI / UDI-DI
- 08588009909002
- Basic UDI-DI
- 8588009909SeerlinqHCWA
- Direct Marketing DI
- 08588009909002
- EMDN Code
- Z12050892 Cardiac telemetry instruments - medical device software
- Device Class
- Class IIb
- Special Device Type
- Software
- Market of Registration
- Slovakia
Manufacturer details
- EUDAMED SRN
- SK-MF-000040803
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 00a1e818-7e58-48ef-9908-c99cdb2d351f