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Medicore Co., Ltd
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SA-3000PModel Heart Rate Variability Analysis System
Identity
- Trade Name
- Medicore Co., Ltd EUDAMED
- Device Name
- SA-3000P EUDAMED
- Model / Reference
- Heart Rate Variability Analysis System EUDAMEDSA-3000P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800021400009 EUDAMED
- Basic UDI-DI
- 88000214000067 EUDAMED
- Direct Marketing DI
- 08800021400009 EUDAMED
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medicore Co., Ltd by Medicore Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073323 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000214000067 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medicore Co., Ltd
- EUDAMED SRN
- KR-MF-000041156
- Authorised Representative
- MedSystem s.r.o. CZ-AR-000040604
Sources (2)
- EUDAMED 2aaec42f-9801-42db-879e-e78ebcc535fa 61 fields · synced Jul 12, 2026
- FDA 510(k) K073323 1 fields · synced May 18, 2026