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aneroid sphygmomanometer
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref BK2001-3002Model BK2001, BK2002, BK2005, BK2001-3001, BK2001-3002, BK2001-3003, BK2003, BK2004, BK2009, BK2099, BK2015, BK2012, BK2066, BK2006, BK2007510(k) K173246
Identity
- Trade Name
- aneroid sphygmomanometer EUDAMED
- Device Name
- aneroid sphygmomanometer EUDAMED
- Model / Reference
- BK2001, BK2002, BK2005, BK2001-3001, BK2001-3002, BK2001-3003, BK2003, BK2004, BK2009, BK2099, BK2015, BK2012, BK2066, BK2006, BK2007 EUDAMEDBK2001-3002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931038620127 EUDAMED
- Basic UDI-DI
- 69310386ANE001BP EUDAMED
- EMDN Code
- C9006 ANEROID SPHYGMOMANOMETERS EUDAMED
Classification
- Device Class
- Class I 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
aneroid sphygmomanometer by Wenzhou Bokang Instruments Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173246 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69310386ANE001BP | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Bokang Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000021505
- FDA Applicant
- Wenzhou Bokang Instruments Co., Ltd.
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 1a985e51-5434-4acd-bcef-af852b732eb4 85 fields · synced Jun 18, 2026
- FDA 510(k) K173246 1 fields · synced May 18, 2026