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Digital Automatic Blood Pressure Monitor
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref MD2540Ref MD5611Ref MD3151Ref MD41A0Ref MD5940510(k) K120675
Identity
- Trade Name
- Digital Automatic Blood Pressure Monitor MD5611 EUDAMEDDigital Automatic Blood Pressure Monitor - MD3151 EUDAMEDDigital Automatic Blood Pressure Monitor - MD41A0 EUDAMEDDigital Automatic Blood Pressure Monitor MD5940 EUDAMEDDigital Automatic Blood Pressure Monitor - MD2540 EUDAMEDBelifu FDA UDIG.LAB FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Digital Automatic Blood Pressure Monitor EUDAMED
- Model / Reference
- MD2540 EUDAMEDMD5611 EUDAMEDMD3151 EUDAMEDFDA UDIMD41A0 EUDAMEDMD5940 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04895045403314 EUDAMED04895045404403 EUDAMED04895045403819 EUDAMEDFDA UDI04895045404212 EUDAMED04895045404021 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04895045403314 EUDAMED48950454001U3 EUDAMEDB-04895045404212 EUDAMEDB-04895045404403 EUDAMEDB-04895045403819 EUDAMEDB-04895045404021 EUDAMED
- Direct Marketing DI
- 04895045404403 EUDAMED04895045403819 EUDAMED04895045404212 EUDAMED04895045404021 EUDAMED04895045403314 EUDAMED
- 510(k) Number
- K120675 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Digital Automatic Blood Pressure Monitor by Grandway Technology (shenzhen) Limited — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120675 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-04895045403314 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04895045403314 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Grandway Technology (Shenzhen) Limited
- EUDAMED SRN
- CN-MF-000009310
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (13)
- EUDAMED 29d99ac2-b87f-4f07-84a0-d3968d5a5b0c 61 fields · synced Sep 18, 2026
- EUDAMED ff81b2fa-fa4a-488e-a00e-4375203ec56f 61 fields · synced May 17, 2026
- EUDAMED d2f73a10-ab2e-44de-a35d-a9fee6b9358f 61 fields · synced May 18, 2026
- EUDAMED 93fecdaf-72a5-43b9-83aa-4202bcb9a009 61 fields · synced May 18, 2026
- EUDAMED 81772660-f33c-49f9-97b5-4c885e690d93 61 fields · synced May 18, 2026
- FDA 510(k) K120675 24 fields · synced May 18, 2026
- FDA UDI e0527bdc-40b3-445c-adba-137c3039521e 32 fields · synced May 30, 2026
- FDA UDI 13bddb93-8971-4ea6-b69c-d812d44287f7 32 fields · synced May 30, 2026
- EUDAMED 54c25c8a-6def-4f00-88ce-901c4a685992 61 fields · synced Jul 14, 2026
- EUDAMED 89cb8db5-bdd5-481e-866d-88f218a9bd88 61 fields · synced Jul 29, 2026
- EUDAMED 79706f90-5f43-4327-be40-e3afdecd50da 61 fields · synced Jul 29, 2026
- EUDAMED 3d51eadd-485d-4e5b-a420-f5a7c9e424ac 61 fields · synced Jul 31, 2026
- EUDAMED bf42b587-7f77-440b-a187-8b4f205e30a6 61 fields · synced Sep 18, 2026