Identity
- Trade Name
- EM-01 EUDAMED
- Device Name
- EM-01 - wireless ECG module EUDAMED
- Model / Reference
- EM-01 EUDAMEDEM01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59044737177464 EUDAMED
- Basic UDI-DI
- B-59044737177464 EUDAMED
- EMDN Code
- Z12050803 ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Em-01 by EMTEL Śliwa spółka komandytowa — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-59044737177464 | Class IIb | Active |
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Manufacturer
- Manufacturer
- EMTEL Śliwa spółka komandytowa
- EUDAMED SRN
- PL-MF-000006848
Sources (1)
- EUDAMED 7dfa1da2-49c2-4651-bbb3-1f236def8828 61 fields · synced Jun 18, 2026