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Ambulatory Electrocardiographs
EUDAMEDClass IIa (EU MDR)
Ref 90310184-01Model iH-12PLUS，iH-3PLUSRef 90310181-01
Identity
- Trade Name
- Ambulatory Electrocardiographs EUDAMED
- Device Name
- Ambulatory Electrocardiographs EUDAMED
- Model / Reference
- iH-12PLUS，iH-3PLUS EUDAMED90310184-01 EUDAMED90310181-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937683471213 EUDAMED06937683471114 EUDAMED
- Basic UDI-DI
- 69376834iHLQ EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Ambulatory Electrocardiographs by Shenzhen Biocare Bio-Medical Equipment 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 | 69376834iHLQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000005653
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED fc609171-b040-4488-a194-7ea470706f99 61 fields · synced Oct 6, 2026
- EUDAMED 3d2c54e8-55e5-4a7f-bf76-73a07dc4172e 61 fields · synced May 18, 2026