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Electrocardiograph
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NeoECG T180510(k) K113485Ref NeoECG S120Ref ECG-1103BRef PCECG-500Ref ECG-1112DRef LeECG OT12Ref ECG-1103GWRef ECG-1112Ref ECG-1103G (I)Model ECG-1103G(I)Ref ECG-1103LW
Identity
- Device Name
- Electrocardiograph EUDAMED
- Model / Reference
- NeoECG T180 EUDAMEDNeoECG S120 EUDAMEDECG-1103B EUDAMEDPCECG-500 EUDAMEDECG-1112D EUDAMEDLeECG OT12 EUDAMEDECG-1103GW EUDAMEDECG-1112 EUDAMEDECG-1103G(I) EUDAMEDECG-1103G (I) EUDAMEDECG-1103LW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971049341697 EUDAMED06971049341574 EUDAMED06971049340140 EUDAMED06971049341291 EUDAMED06971049341093 EUDAMED06971049341604 EUDAMED06971049341796 EUDAMED06971049341628 EUDAMED06971049340164 EUDAMED06971049341086 EUDAMED06971049340256 EUDAMED06971049340188 EUDAMED
- Basic UDI-DI
- B-06971049341697 EUDAMEDB-06971049341574 EUDAMEDB-06971049340140 EUDAMEDB-06971049341291 EUDAMEDB-06971049341093 EUDAMEDB-06971049341604 EUDAMEDB-06971049341796 EUDAMEDB-06971049341628 EUDAMEDB-06971049340164 EUDAMEDB-06971049341086 EUDAMEDB-06971049340256 EUDAMEDB-06971049340188 EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Electrocardiograph by Shenzhen Carewell EIectronics Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113485 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971049341697 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Carewell EIectronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000026800
- FDA Applicant
- Shenzhen Carewell Electronics Co., Ltd.
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (13)
- EUDAMED e3055030-5d2b-46a2-b96b-d0481f6eb6c3 85 fields · synced Oct 6, 2026
- EUDAMED cf478088-0fe0-4e33-b189-84f3abacc2ed 61 fields · synced Jul 10, 2026
- EUDAMED 482d570d-8d1d-4576-b20f-b323d98dfbea 61 fields · synced Jul 15, 2026
- EUDAMED 2380d834-d6c2-41a3-adcc-4de3b2b8180d 61 fields · synced Jul 16, 2026
- EUDAMED 858d6ba5-044e-4dfe-9799-3d9ca66a0601 61 fields · synced Jul 20, 2026
- EUDAMED a84b3581-feea-4352-9dfc-0006cd19f744 61 fields · synced Jul 20, 2026
- EUDAMED 4d66d625-ad98-4cde-b625-cec47b8ac1c6 61 fields · synced Jul 21, 2026
- EUDAMED 23c87818-ba2d-4d13-89a3-ef04e3ff5227 61 fields · synced Jul 24, 2026
- EUDAMED 7be105ef-75b5-4846-b227-fec205770141 61 fields · synced Jul 25, 2026
- EUDAMED 6b4f15e9-6945-4761-8877-f43f4f1fc63d 61 fields · synced Jul 26, 2026
- EUDAMED be5af557-d94f-49f0-8316-90f8ada2bea2 61 fields · synced Jul 26, 2026
- EUDAMED 5d895dca-657d-46f4-abd0-3fdd277c1840 61 fields · synced Jul 29, 2026
- FDA 510(k) K113485 1 fields · synced May 18, 2026