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Electronic sphygmomanometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BK6002Model BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032
Identity
- Trade Name
- Electronic sphygmomanometer EUDAMEDBOKANG FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
- Device Name
- Electronic sphygmomanometer EUDAMED
- Model / Reference
- BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032 EUDAMEDBK6002 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06931038660024 EUDAMEDFDA UDI
- Basic UDI-DI
- 69310386ELC001C7 EUDAMED
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- C9006 ANEROID SPHYGMOMANOMETERS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Electronic sphygmomanometer by Wenzhou Bokang Instruments Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69310386ELC001C7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED a4cb83c5-f99a-4409-8854-cf2cee435ad4 61 fields · synced Jul 8, 2026
- FDA UDI 1bc2296a-5e40-4986-8c67-adbd0002a08b 32 fields · synced May 30, 2026