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Wellue
EUDAMEDClass IIa (EU MDR)
Ref LepodModel M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12
Identity
- Trade Name
- Wellue EUDAMED
- Device Name
- Wireless Dynamic Multi-parameter Holter EUDAMED
- Model / Reference
- M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12 EUDAMEDLepod EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934440102137 EUDAMED
- Basic UDI-DI
- 69344401M12WA EUDAMED
- Direct Marketing DI
- 06934440102137 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
Wellue 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 3fe30725-0ac3-4881-86b9-662a2c70e24c 61 fields · synced Jun 15, 2026