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Wrist Type Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref BPM15Model BPW26510(k) K102624
Identity
- Trade Name
- Wrist Type Blood Pressure Monitor EUDAMED
- Device Name
- Wrist Type Blood Pressure Monitor EUDAMED
- Model / Reference
- BPW26 EUDAMEDBPM15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710953420683 EUDAMED
- Basic UDI-DI
- 471095342TCF02BPWJH EUDAMED
- Direct Marketing DI
- 04710953420683 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wrist Type Blood Pressure Monitor by Avita Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K200346 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K102624 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 471095342TCF02BPWJH | Class IIa | Active |
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Manufacturer
- Manufacturer
- AViTA Corporation
- EUDAMED SRN
- TW-MF-000010455
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 9486f9e1-f8aa-4916-8536-9d24b7143d75 85 fields · synced Jun 19, 2026
- FDA 510(k) K200346 1 fields · synced May 18, 2026