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Electronic sphygmomanometer
EUDAMEDClass IIa (EU MDR)
Ref BK1016TModel BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032
Identity
- Device Name
- Electronic sphygmomanometer EUDAMED
- Model / Reference
- BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032 EUDAMEDBK1016T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931038610135 EUDAMED
- Basic UDI-DI
- 69310386ELC001C7 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Electronic sphygmomanometer by Wenzhou Bokang Instruments 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 | 69310386ELC001C7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wenzhou Bokang Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000021505
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1f1cec07-644a-4a74-83b3-b7c0fd980d0c 61 fields · synced Jun 19, 2026