Identity
- Device Name
- Holter Recorder EUDAMED
- Model / Reference
- TH3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971049341260 EUDAMED
- Basic UDI-DI
- B-06971049341260 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS 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
Holter Recorder by Shenzhen Carewell EIectronics Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971049341260 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Carewell EIectronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000026800
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED c0a2c724-562c-44b7-a4d1-ba26e5113038 61 fields · synced Oct 6, 2026