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BTL Flexi 12 ECG
EUDAMEDClass IIa (EU MDR)
Ref C076.014; C076.013; C076.004; C076.003
Identity
- Trade Name
- BTL Flexi 12 ECG EUDAMED
- Device Name
- BTL Flexi 12 ECG EUDAMED
- Model / Reference
- C076.014; C076.013; C076.004; C076.003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B108076POFF12MEU00 EUDAMED
- Basic UDI-DI
- ++B108076POEUZF EUDAMED
- Direct Marketing DI
- B108076POFF12MEU00 EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa 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 Flexi 12 ECG 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 | ++B108076POEUZF | 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 (2)
- EUDAMED b836c8d8-f3a1-4ddc-9466-1263c7f71e87 61 fields · synced Jul 11, 2026
- EUDAMED b836c8d8-f3a1-4ddc-9466-1263c7f71e87-1 61 fields · synced Jun 9, 2026