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Wireless Dynamic Multi-parameter Holter
EUDAMEDClass IIa (EU MDR)
Ref Lepod ProModel M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12
Identity
- Device Name
- Wireless Dynamic Multi-parameter Holter EUDAMED
- Model / Reference
- M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12 EUDAMEDLepod Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934440102144 EUDAMED
- Basic UDI-DI
- 69344401M12WA EUDAMED
- Direct Marketing DI
- 06934440102144 EUDAMED
- EMDN Code
- Z12050402 MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Wireless Dynamic Multi-parameter Holter by Shenzhen Viatom Technology Co., Ltd. — 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 | 69344401M12WA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Viatom Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012182
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 26aa3f62-0ca0-43f7-b33f-88700cace6e2 61 fields · synced Jul 31, 2026