Alvita
by Guangdong Transtek Medical Electronics Co., Ltd.
Ref TMB-1491-SModel TMB-1491-SN, TMB-1491-DS, TMB-1491-S, TMB-2283-K, TMB- 2283
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 | Number69328253TMB1491PE | Date3 Nov 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- Withdrawn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
- Device Name
- Blood Pressure Monitor
- Model / Reference
- TMB-1491-SN, TMB-1491-DS, TMB-1491-S, TMB-2283-K, TMB- 2283
- Primary DI / UDI-DI
- 06932825304671, 06932825304688
- Basic UDI-DI
- 69328253TMB1491PE
- Direct Marketing DI
- 0693282530467106932825304688
- EMDN Code
- Z1203020501 Non–invasive oscillometric blood pressure gauges
- Device Class
- Class IIa
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000010684
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Guangdong Transtek Medical Electronics Co., Ltd
See all devices from Guangdong Transtek Medical Electronics Co., Ltd →
Properties
Other properties (13)
- 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
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No