Arm Type Blood Pressure Monitor
by AViTA Corporation 12 variants
Ref BPM653-00SModel NA090
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471095342TCF01BPAGW 04710953423462 | Date20 Aug 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- NA090, BPM653-00S
- Primary DI / UDI-DI
- 04710953423462
- Basic UDI-DI
- 471095342TCF01BPAGW
- Direct Marketing DI
- 04710953423462
- EMDN Code
- Z1203020501 Non–invasive oscillometric blood pressure gauges
- Device Class
- Class IIa
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TW-MF-000010455
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Avita Corporation
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Incorporates Medicinal Product: No