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Digital Automatic Blood Pressure Monitor - MD2400
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref MD2400
Identity
- Trade Name
- Digital Automatic Blood Pressure Monitor - MD2400 EUDAMED
- Device Name
- Digital Automatic Blood Pressure Monitor EUDAMED
- Model / Reference
- MD2400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04895045404878 EUDAMED
- Basic UDI-DI
- 48950454001U3 EUDAMEDB-04895045404878 EUDAMED
- Direct Marketing DI
- 04895045404878 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Digital Automatic Blood Pressure Monitor - MD2400 by Grandway Technology (shenzhen) Limited — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143735 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 48950454001U3 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 48950454001U3 | 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 (3)
- EUDAMED 949f604b-b794-454d-ae04-bae158f39a50 61 fields · synced Oct 6, 2026
- EUDAMED e6803101-5130-4a20-bc8f-470b4d1d5d10 61 fields · synced May 17, 2026
- FDA 510(k) K143735 1 fields · synced May 18, 2026