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Lepu Medical
EUDAMEDClass IIa (EU MDR)
Ref PO4Model PO2, PO4，PO2A，PO2B，PO2S，PO2C，PO2C-A，PO2C-S， PO4S，PO4C，PO4C-SRef ER1-LBModel ER1-LW，ER1-LBRef M5Model M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12Ref R10Model LeRes-S, LeRes-A, LeRes-B, LeRes-C, R100, R10, R200, R20Ref ER1-LWRef LMT-5Ref R20Ref LepodRef BP2BModel BP2，BP2B，BP2V，BP2WRef LeRes-SRef M12Ref LeRes-ARef BP3FModel BP3F, BP3G, HDM3F, HDM3GRef HDM3GRef R100Ref ER2-SRef iHolter-3Model XAB-M3AG、 XAB-M12AL、 iHolter-3、 iHolter-12、 LeHolter-3、 LeHolter-12Ref XAB-M3AGRef EHL-1DRef PF-10AWModel PF-10AW、PF- 10AW1、PF-10A、PF-10A1、PF-10BW、PF- 10BW1、PF-10B、PF-10B1
Identity
- Trade Name
- LEPU MEDICAL EUDAMEDLEPU EUDAMED
- Device Name
- Pulse Oximeter EUDAMEDDynamic ECG Recorder EUDAMEDWireless Dynamic Multi-parameter Holter EUDAMEDNon-invasive Ventilator EUDAMEDBlood Pressure Monitor EUDAMEDBlood Pressure Monitor with ECG EUDAMEDECG Recorder EUDAMED
- Model / Reference
- PO2, PO4，PO2A，PO2B，PO2S，PO2C，PO2C-A，PO2C-S， PO4S，PO4C，PO4C-S EUDAMEDPO4 EUDAMEDER1-LW，ER1-LB EUDAMEDER1-LB EUDAMEDM5，M12，Lepod，Lepod Pro，LMT-5，LMT-12 EUDAMEDM5 EUDAMEDLeRes-S, LeRes-A, LeRes-B, LeRes-C, R100, R10, R200, R20 EUDAMEDR10 EUDAMEDER1-LW EUDAMEDLMT-5 EUDAMEDR20 EUDAMEDLepod EUDAMEDBP2，BP2B，BP2V，BP2W EUDAMEDBP2B EUDAMEDLeRes-S EUDAMEDM12 EUDAMEDLeRes-A EUDAMEDBP3F, BP3G, HDM3F, HDM3G EUDAMEDBP3F EUDAMEDHDM3G EUDAMEDR100 EUDAMEDER2-S EUDAMEDXAB-M3AG、 XAB-M12AL、 iHolter-3、 iHolter-12、 LeHolter-3、 LeHolter-12 EUDAMEDiHolter-3 EUDAMEDXAB-M3AG EUDAMEDEHL-1D EUDAMEDPF-10AW、PF- 10AW1、PF-10A、PF-10A1、PF-10BW、PF- 10BW1、PF-10B、PF-10B1 EUDAMEDPF-10AW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934440103844 EUDAMED06934440102052 EUDAMED06934440102120 EUDAMED06934440103158 EUDAMED06934440102625 EUDAMED06934440102632 EUDAMED06934440102151 EUDAMED06934440103097 EUDAMED06934440103455 EUDAMED06934440103271 EUDAMED06934440102663 EUDAMED06934440101963 EUDAMED06934440103134 EUDAMED06934440103028 EUDAMED06934440103554 EUDAMED06934440103141 EUDAMED06934440102731 EUDAMED06934440102656 EUDAMED06934440103325 EUDAMED06934440103318 EUDAMED06934440103684 EUDAMED06934440103899 EUDAMED
- Basic UDI-DI
- 69344401PO2ZG EUDAMED69344401ER1-LWER EUDAMED69344401M12WA EUDAMED69344401LeRes-SFU EUDAMED69344401BP2XD EUDAMED69344401BP3FNL EUDAMED69344401ER2-SHM EUDAMED69344401iHolter-12LM EUDAMED69344401PF-10AW9D EUDAMED
- Direct Marketing DI
- 06934440103844 EUDAMED06934440102052 EUDAMED06934440102120 EUDAMED06934440103158 EUDAMED06934440102625 EUDAMED06934440102632 EUDAMED06934440102151 EUDAMED06934440103097 EUDAMED06934440103455 EUDAMED06934440103271 EUDAMED06934440102663 EUDAMED06934440101963 EUDAMED06934440103134 EUDAMED06934440103028 EUDAMED06934440103554 EUDAMED06934440103141 EUDAMED06934440102731 EUDAMED06934440102656 EUDAMED06934440103325 EUDAMED06934440103318 EUDAMED06934440103684 EUDAMED06934440103899 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMEDZ12050403 ECG HOLTER RECORDERS EUDAMEDZ12050402 MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.) EUDAMEDZ1203010502 ADULT PULMONARY VENTILATORS EUDAMEDZ1203020302,Z12050301 EUDAMEDZ12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS 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
EUDAMEDEUDAMED
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 | 69344401PO2ZG | 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 (22)
- EUDAMED 8b4e681a-7124-46b4-8c12-ef0bf40b2bda 61 fields · synced Aug 4, 2026
- EUDAMED 8246c7d0-3370-449f-9a51-3756545c92af 61 fields · synced May 16, 2026
- EUDAMED b0acfa45-4b2f-4e0d-8a8d-cfa773a863ea 61 fields · synced May 17, 2026
- EUDAMED 4fd458a8-189e-4556-8267-0da34bf4af04 61 fields · synced May 17, 2026
- EUDAMED f39328f1-d201-4458-999f-504e5190dfc4 61 fields · synced May 17, 2026
- EUDAMED 4d703767-42b3-4af4-8acd-7133aa23c992 61 fields · synced May 17, 2026
- EUDAMED ed773fd1-fd7f-45ab-a892-73c808c1d4b2 61 fields · synced May 17, 2026
- EUDAMED b09960bf-2f57-481a-bcbd-c99f5fe2d501 61 fields · synced May 17, 2026
- EUDAMED eed8576c-e4ec-4e57-a71e-11f3fe1c6231 61 fields · synced May 18, 2026
- EUDAMED a52bdd78-fab2-4c20-9885-38532c95defc 61 fields · synced May 18, 2026
- EUDAMED 467bda9c-6b7a-400e-acde-fcb81fbbbbca 61 fields · synced May 18, 2026
- EUDAMED 35d1731b-0d61-4d13-ad9a-968c4bbcbb95 61 fields · synced May 18, 2026
- EUDAMED 36863198-f83e-453e-bfc3-4f00b5ddf01b 61 fields · synced May 18, 2026
- EUDAMED 6fd6bb08-d401-4e3b-a388-fc21f6b7778c 61 fields · synced May 18, 2026
- EUDAMED d5de74e1-2d01-4ad5-9ef7-93bf24b68f4f 61 fields · synced May 18, 2026
- EUDAMED 40d73443-d221-497e-bdcc-c9c2767ebb46 61 fields · synced May 19, 2026
- EUDAMED b6492420-f124-4c5d-8268-760af30ce088 61 fields · synced May 19, 2026
- EUDAMED c9c104dd-23b6-4055-b94a-3705c870678f 61 fields · synced May 19, 2026
- EUDAMED 3b3fa238-6ad2-4ef5-93cf-9ccfdfa82827 61 fields · synced Jul 17, 2026
- EUDAMED 1565f282-c23c-409d-ba91-40f0139f2e21 61 fields · synced Jul 25, 2026
- EUDAMED b5241641-fdde-4124-b499-9cf020fae737 61 fields · synced Jul 29, 2026
- EUDAMED b29b2d55-b896-4d47-a9ce-50b81c7bc2ed 61 fields · synced Aug 1, 2026