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Medicore Co., Ltd
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Max PulseModel Heart Rate Variability Analysis System510(k) K110374
Identity
- Trade Name
- Medicore Co., Ltd EUDAMED
- Device Name
- Max Pulse EUDAMED
- Model / Reference
- Heart Rate Variability Analysis System EUDAMEDMax Pulse EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800021400047 EUDAMED
- Basic UDI-DI
- 8800021400046F EUDAMED
- Direct Marketing DI
- 08800021400047 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 | K110374 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8800021400046F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medicore Co., Ltd
- EUDAMED SRN
- KR-MF-000041156
- FDA Applicant
- Medicore Co., Ltd.
- Authorised Representative
- MedSystem s.r.o. CZ-AR-000040604
Sources (2)
- EUDAMED d2c5f079-9ed4-4dbc-97ef-5e8c23567c52 85 fields · synced Jun 18, 2026
- FDA 510(k) K110374 1 fields · synced May 18, 2026