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Upper Arm Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZK-B885Model JZK-301，JZK-303, JZK-305, JZK-307
Identity
- Trade Name
- Upper Arm Blood Pressure Monitor EUDAMEDJZIKI FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Oximeter EUDAMED
- Model / Reference
- JZK-301，JZK-303, JZK-305, JZK-307 EUDAMEDZK-B885 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06922119301387 EUDAMEDFDA UDI
- Basic UDI-DI
- 69221193XSY EUDAMED
- 510(k) Number
- K191894 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Spain 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Upper Arm Blood Pressure Monitor by Shenzhen Zhengkang Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69221193XSY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ShenZhen ZhengKang Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038997
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED b58e336a-778e-45f2-ae02-e51d9718ff55 61 fields · synced Oct 5, 2026
- FDA UDI aa19b00e-efd4-46bb-827e-eea7654fdfac 33 fields · synced May 25, 2026