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Checkme
EUDAMEDClass IIa (EU MDR)
Ref ER1-LWModel ER1-LW，ER1-LBRef ER2-SRef Lepod ProModel M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12Ref BP2VModel BP2，BP2B，BP2V，BP2WRef ER2-SCRef EPatch-DRef EPatch-TRef BP2B
Identity
- Trade Name
- Checkme EUDAMED
- Device Name
- Dynamic ECG Recorder EUDAMEDECG Recorder EUDAMEDWireless Dynamic Multi-parameter Holter EUDAMEDBlood Pressure Monitor EUDAMED
- Model / Reference
- ER1-LW，ER1-LB EUDAMEDER1-LW EUDAMEDER2-S EUDAMEDM5，M12，Lepod，Lepod Pro，LMT-5，LMT-12 EUDAMEDLepod Pro EUDAMEDBP2，BP2B，BP2V，BP2W EUDAMEDBP2V EUDAMEDER2-SC EUDAMEDEPatch-D EUDAMEDEPatch-T EUDAMEDBP2B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934440102717 EUDAMED06934440101925 EUDAMED06934440102779 EUDAMED06934440101949 EUDAMED06934440101932 EUDAMED06934440103660 EUDAMED06934440103677 EUDAMED06934440102076 EUDAMED
- Basic UDI-DI
- 69344401ER1-LWER EUDAMED69344401ER2-SHM EUDAMED69344401M12WA EUDAMED69344401BP2XD EUDAMED69344401ER2-SCED EUDAMED
- Direct Marketing DI
- 06934440102717 EUDAMED06934440101925 EUDAMED06934440102779 EUDAMED06934440101949 EUDAMED06934440101932 EUDAMED06934440103660 EUDAMED06934440103677 EUDAMED06934440102076 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMEDZ12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMEDZ12050402 MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.) EUDAMEDZ1203020302,Z12050301 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
Checkme 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 | 69344401ER1-LWER | 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 (8)
- EUDAMED 610d01dd-f765-4794-bc93-fc97f0bb9433 61 fields · synced Aug 4, 2026
- EUDAMED 42ee5eaf-a488-41ff-9f85-51776cd53b76 61 fields · synced May 17, 2026
- EUDAMED 99c8883f-e91a-41b8-8f7e-12ea3a98dfb9 61 fields · synced May 17, 2026
- EUDAMED acc2e485-4426-4643-bf62-4e4eb0b3a0d8 61 fields · synced May 18, 2026
- EUDAMED 7bb28284-277e-4419-b5f9-432546e75c00 61 fields · synced May 18, 2026
- EUDAMED b85b67ed-0060-49b9-a27e-39f3e0f362ee 61 fields · synced Jul 10, 2026
- EUDAMED b1854c72-d892-41db-88ca-34132d330f8e 61 fields · synced Jul 15, 2026
- EUDAMED 0bebbe04-b7f7-4a76-aee5-7d155129e8a0 61 fields · synced Aug 3, 2026