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sfigmomanometro
EUDAMEDClass I (EU MDR)
Ref 2202617200Model BK2001, BK2002, BK2005, BK2001-3001, BK2001-3002, BK2001-3003, BK2003, BK2004, BK2009, BK2099, BK2015, BK2012, BK2066, BK2006, BK2007Ref 2202617300Ref 2202615300Ref 2202615400
Identity
- Trade Name
- sfigmomanometro 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 EUDAMED2202617200 EUDAMED2202617300 EUDAMED2202615300 EUDAMED2202615400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931038626020 EUDAMED06931038626037 EUDAMED06931038626051 EUDAMED06931038626044 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
- 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
sfigmomanometro 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 (4)
- EUDAMED b6c4243e-d219-4b2b-9ba6-97bd837c09f5 61 fields · synced Jul 20, 2026
- EUDAMED 6d46b899-525e-48d1-9798-ff4b3ac3c7e7 61 fields · synced May 17, 2026
- EUDAMED 06f0a5ab-017a-4584-bb7d-199c183a6cb0 61 fields · synced May 18, 2026
- EUDAMED 74e2f1ee-9be1-47f4-ac68-9dddc8116df6 61 fields · synced May 18, 2026