Identity
- Trade Name
- BTL CardioPoint EUDAMED
- Device Name
- BTL CardioPoint EUDAMED
- Model / Reference
- 590-CP-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- B108590CPMEU00 EUDAMED
- Basic UDI-DI
- ++B108590SWK6 EUDAMED
- Direct Marketing DI
- B108590CPMEU00 EUDAMED
- EMDN Code
- Z129082 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Northern Ireland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BTL CardioPoint by BTL Industries Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B108590SWK6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BTL Industries Limited
- EUDAMED SRN
- GB-MF-000034894
- Authorised Representative
- BTL ITALIA S.r.l. IT-AR-000020508
Sources (1)
- EUDAMED 8ae4ce50-7cf3-4d42-acf2-cedaefbf9043 61 fields · synced Jul 19, 2026