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Ambulatory Blood Pressure Svstem
EUDAMEDClass IIa (EU MDR)
Ref G5601Model BI5000Ref G5602Model BI5000B
Identity
- Device Name
- Ambulatory Blood Pressure Svstem EUDAMED
- Model / Reference
- BI5000 EUDAMEDG5601 EUDAMEDBI5000B EUDAMEDG5602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970912080343 EUDAMED06970912080350 EUDAMED
- Basic UDI-DI
- B-06970912080343 EUDAMEDB-06970912080350 EUDAMED
- EMDN Code
- Z12050404 BLOOD PRESSURE HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ambulatory Blood Pressure Svstem by Biomedical Instruments 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-06970912080343 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biomedical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000016483
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 7767bc26-798f-4888-a058-ffa05f643acd 61 fields · synced Oct 6, 2026
- EUDAMED ded0bd99-8189-4981-b526-655a4b91c2f4 61 fields · synced May 18, 2026