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wrist blood pressure monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref W1681Ref W202
Identity
- Trade Name
- wrist blood pressure monitor EUDAMEDaleshon FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- wrist blood pressure monitor EUDAMED
- Model / Reference
- W1681 EUDAMEDFDA UDIW202 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971209160038 EUDAMEDFDA UDI06971209160021 EUDAMEDFDA UDI
- Basic UDI-DI
- 697120916W1681AG EUDAMED697120916W202EB EUDAMED
- Direct Marketing DI
- 06971209160021 EUDAMED
- 510(k) Number
- K211041 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- C9006 ANEROID SPHYGMOMANOMETERS 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
- Germany 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
Yes
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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
wrist blood pressure monitor by Shenzhen Yuezhongxing 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 | 697120916W1681AG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Yuezhongxing Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000024102
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (4)
- EUDAMED b8c10843-c796-4e47-9155-9f1aaa200fd4 61 fields · synced Oct 6, 2026
- FDA UDI 5328186d-47a8-4d91-986f-150f50407098 33 fields · synced May 30, 2026
- FDA UDI 8879c120-d0a1-4355-84a1-c569c650eb44 33 fields · synced May 30, 2026
- EUDAMED 1ac7e040-c62a-4b8e-8867-8898c44feae2 61 fields · synced Aug 3, 2026