← Back to catalogue
Electronic sphygmomanometer
EUDAMEDClass IIa (EU MDR)
Ref BK1016Model BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032
Identity
- Trade Name
- Electronic sphygmomanometer EUDAMED
- Device Name
- Electronic sphygmomanometer EUDAMED
- Model / Reference
- BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032 EUDAMEDBK1016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931038610197 EUDAMED
- Basic UDI-DI
- 69310386ELC001C7 EUDAMED
- EMDN Code
- C9006 ANEROID SPHYGMOMANOMETERS 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 |
Is this your device? Claim it to add documentation and request validation.
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 d93e3f16-c844-4155-9a00-ca07bc0373a3 61 fields · synced Jun 18, 2026