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Ambulatory Blood Pressure Recorders and Associated Software
EUDAMEDClass IIa (EU MDR)
Ref 90310911Model iH-B
Identity
- Trade Name
- Ambulatory Blood Pressure Recorders and Associated Software EUDAMED
- Device Name
- Ambulatory Blood Pressure Recorders and Associated Software EUDAMED
- Model / Reference
- iH-B EUDAMED90310911 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937683471527 EUDAMED
- Basic UDI-DI
- 69376834iHBB5 EUDAMED
- EMDN Code
- Z12050404 BLOOD PRESSURE HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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 Blood Pressure Recorders and Associated Software by Shenzhen Biocare Bio-Medical Equipment Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 69376834iHBB5 | 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 (1)
- EUDAMED 3841ab9e-12d2-4524-b8cc-971b293709cf 61 fields · synced Oct 6, 2026