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aneroid sphygmomanometer
EUDAMEDFDA UDIClass I (EU MDR)
Ref BK2002Model BK2001, BK2002, BK2005, BK2001-3001, BK2001-3002, BK2001-3003, BK2003, BK2004, BK2009, BK2099, BK2015, BK2012, BK2066, BK2006, BK2007
Identity
- Trade Name
- aneroid sphygmomanometer EUDAMEDBOKANG FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- aneroid sphygmomanometer EUDAMEDANEROID SPHYGMOMANOMETER is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include additional stethoscope. It is conjunction with Stethoscope when use. FDA UDI
- Model / Reference
- BK2001, BK2002, BK2005, BK2001-3001, BK2001-3002, BK2001-3003, BK2003, BK2004, BK2009, BK2099, BK2015, BK2012, BK2066, BK2006, BK2007 EUDAMEDBK2002 EUDAMEDFDA UDI
- Description
- ANEROID SPHYGMOMANOMETER is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include additional stethoscope. It is conjunction with Stethoscope when use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06931038620202 EUDAMEDFDA UDI
- Basic UDI-DI
- 69310386ANE001BP EUDAMED
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- C9006 ANEROID SPHYGMOMANOMETERS EUDAMED
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 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
Yes
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
aneroid sphygmomanometer by Wenzhou Bokang Instruments Co., Ltd — Class I — 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 | 69310386ANE001BP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 4f14f494-349b-4c9d-baf5-e08ba31f25cf 61 fields · synced Jul 8, 2026
- FDA UDI 2bc79c73-06fa-4e1f-a60d-e363f8e31e3b 33 fields · synced May 29, 2026