Identity
- Trade Name
- BIATRODES EUDAMED
- Device Name
- Low-impedance disposable electrodes for bioimpedance analysis EUDAMED
- Model / Reference
- 0ELB100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80515774700262 EUDAMED
- Basic UDI-DI
- 805157747ELBKZ EUDAMED
- Direct Marketing DI
- 80515774700262 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Category: Electrocardiographic electrode, single-use
Biatrodes by Akern Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 805157747ELBKZ | Class I | Active |
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Manufacturer
- Manufacturer
- Akern Srl
- EUDAMED SRN
- IT-MF-000013092
Sources (1)
- EUDAMED 176126f5-78e2-49c8-bb3b-43ae05272d75 61 fields · synced Jul 17, 2026