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Digital Automatic Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref MD3600
Identity
- Trade Name
- Digital Automatic Blood Pressure Monitor - MD3600 EUDAMED
- Device Name
- Digital Automatic Blood Pressure Monitor EUDAMED
- Model / Reference
- MD3600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04895045404953 EUDAMED
- Basic UDI-DI
- B-04895045404953 EUDAMED48950454001U3 EUDAMED
- Direct Marketing DI
- 04895045404953 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 by Grandway Technology (shenzhen) Limited — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k)
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 | K163679 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-04895045404953 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04895045404953 | 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 56e9fd2e-51fc-4539-8cdb-386394b257cd 61 fields · synced Oct 6, 2026
- EUDAMED 0c0f8b67-2c29-47cb-a46d-eeb5d00c3f80 61 fields · synced May 18, 2026
- FDA 510(k) K163679 1 fields · synced May 18, 2026