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medisana
EUDAMEDClass IIa (EU MDR)
Ref BP885W(BW 320)Model BP885W，BW 320，BP880W，BPCB0A-2F
Identity
- Trade Name
- medisana EUDAMED
- Device Name
- blood pressure monitor EUDAMED
- Model / Reference
- BP885W，BW 320，BP880W，BPCB0A-2F EUDAMEDBP885W(BW 320) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158400317 EUDAMED
- Basic UDI-DI
- 69481584WRIST01FN EUDAMED
- Direct Marketing DI
- 06948158400317 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
medisana by Shenzhen Combei Technology 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 | 69481584WRIST01FN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Combei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016047
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED dc466fa5-fd43-4363-8f6e-6ce917e015c2 61 fields · synced Jun 18, 2026