Blood Pressure Monitor TMB-2296-B
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Blood Pressure Monitor EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- TMB-2296-B EUDAMEDRule 10 in Chapter III of Annex VIII of the Regulation (EU) 2017/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932825303889 EUDAMED
- Basic UDI-DI
- 69328253MDR06Q2 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
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
The Blood Pressure Monitor TMB-2296-B is a medical device designed to measure a patient's blood pressure. It is classified as a Class IIa device. The device is reusable and is not sterile.
The device is intended for use in a clinical setting. It is not supplied sterile and must be cleaned and disinfected between uses. The device is not implantable, not for use with medicinal products, and does not contain latex or animal tissues.
Frequently asked questions
Is the Blood Pressure Monitor TMB-2296-B reusable?
Yes, the Blood Pressure Monitor TMB-2296-B is a reusable device. It is not intended for single-use and must be cleaned and disinfected between patient uses.
Is the device sterile?
No, the Blood Pressure Monitor TMB-2296-B is not sterile. It is a reusable device that requires cleaning and disinfection before each use.
What is the classification of the Blood Pressure Monitor TMB-2296-B?
The Blood Pressure Monitor TMB-2296-B is classified as a Class IIa medical device. This classification is based on its risk level and intended use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TRNSTEK - accessdata.fda.gov, Transtek Blood Pressure Monitor Manufacturer/Supplier, Blood ..., Transtek Blood Pressure Monitors for Home Use, TeleRPM BPM Gen 2 Plus - Blood Pressure Monitor, TRANSTEK's 4G Blood Pressure Monitor Passed VDL Clinical ...
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202891 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232713 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232621 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K131395 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220676 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K161886 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K223374 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K233130 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69328253MDR06Q2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Transtek Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000010684
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 3573ec06-ae99-4608-bdff-f97026e35d00 61 fields · synced Oct 7, 2026
- FDA 510(k) K202891 1 fields · synced May 18, 2026