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Wrist-type Fully Automatic Digital Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref DBP-2156Ref DBP-21E8bRef DBP-8288BRef DBP-8189Ref DBP-2208
Identity
- Trade Name
- Wrist-type Fully Automatic Digital Blood Pressure Monitor EUDAMEDWrist Type Fully Automatic Digital Blood Pressure Monitor EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMEDWrist-type Fully Automatic Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- DBP-2156 EUDAMEDDBP-21E8b EUDAMEDDBP-8288B EUDAMEDDBP-8189 EUDAMEDDBP-2208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392216447 EUDAMED06942284608579 EUDAMED06970392216928 EUDAMED06970392214337 EUDAMED06970392216423 EUDAMED
- Basic UDI-DI
- 6970392211BP0003Y9 EUDAMED6970392211BP0008YK EUDAMED6970392211BP0007YH EUDAMED6970392211BP0006YF EUDAMED
- Direct Marketing DI
- 06942284608579 EUDAMED06970392216928 EUDAMED06970392214337 EUDAMED06970392216423 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDAustria EUDAMEDGermany EUDAMEDFrance 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
Wrist-type Fully Automatic Digital Blood Pressure Monitor by Joytech Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213189 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6970392211BP0003Y9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- JOYTECH Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000006020
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED 0f7a4e90-1ef8-403b-b2ca-7ca33375f487 61 fields · synced Jul 25, 2026
- EUDAMED 5f67375c-3118-4e96-92bf-1b4229f3e9e0 61 fields · synced May 17, 2026
- EUDAMED 451ee488-33e7-40dd-8bcb-822a419e6fa4 61 fields · synced May 18, 2026
- EUDAMED c3bb5de8-c55b-40aa-ad11-d77fa5456b9b 61 fields · synced May 18, 2026
- EUDAMED 15abdeca-d4d9-4e0d-a01b-7862a7ce7dda 61 fields · synced Jul 14, 2026
- FDA 510(k) K213189 1 fields · synced May 18, 2026