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Lepu Medical
EUDAMEDClass IIa (EU MDR)
Ref R200Model LeRes-S, LeRes-A, LeRes-B, LeRes-C, R100, R10, R200, R20
Identity
- Trade Name
- LEPU MEDICAL EUDAMED
- Device Name
- Non-invasive Ventilator EUDAMED
- Model / Reference
- LeRes-S, LeRes-A, LeRes-B, LeRes-C, R100, R10, R200, R20 EUDAMEDR200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934440103103 EUDAMED
- Basic UDI-DI
- 69344401LeRes-SFU EUDAMED
- Direct Marketing DI
- 06934440103103 EUDAMED
- EMDN Code
- Z1203010502 ADULT PULMONARY VENTILATORS 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lepu Medical 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 | 69344401LeRes-SFU | 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 78e4c4fc-032e-45bd-8551-3688cb57ee57 61 fields · synced Jun 15, 2026