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sphygmomanometer
EUDAMEDClass I (EU MDR)
Ref 10000066-PROModel BK2001, BK2002, BK2005, BK2001-3001, BK2001-3002, BK2001-3003, BK2003, BK2004, BK2009, BK2099, BK2015, BK2012, BK2066, BK2006, BK2007Ref 95188
Identity
- Trade Name
- 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 EUDAMED10000066-PRO EUDAMED95188 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931038610036 EUDAMED06931038620011 EUDAMED
- Basic UDI-DI
- 69310386ANE001BP EUDAMED
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDItaly 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
sphygmomanometer by Wenzhou Bokang Instruments Co., Ltd. — Class I — 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 | 69310386ANE001BP | Class I | 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 (2)
- EUDAMED b7af9353-66e8-4f31-8b24-d90917c0f6ab 61 fields · synced Jul 26, 2026
- EUDAMED 8fa5b44c-f8c2-4b14-82e1-91eaafe07a06 61 fields · synced May 18, 2026