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Transtek
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref TMB-2296-B510(k) K131394Ref TMB-2276Model TMB-2266, TMB-2271, TMB-2271-B, TMB-2271-BK, TMB-2271-A, TMB-2284, TMB-2284-B, TMB-2284-T, TMB-2275, TMB-2275-B, TMB-2275-K, TMB-2272-ZY, TMB-2272-AZY, TMB-1775-ZY, TMB-2276, TMB-2276-B, TMB-2276-ARef TMB-1491-DSModel TMB-1491-SN, TMB-1491-DS, TMB-1491-S, TMB-2283-K, TMB- 2283
Identity
- Trade Name
- Transtek EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- TMB-2296-B EUDAMEDTMB-2266, TMB-2271, TMB-2271-B, TMB-2271-BK, TMB-2271-A, TMB-2284, TMB-2284-B, TMB-2284-T, TMB-2275, TMB-2275-B, TMB-2275-K, TMB-2272-ZY, TMB-2272-AZY, TMB-1775-ZY, TMB-2276, TMB-2276-B, TMB-2276-A EUDAMEDTMB-2276 EUDAMEDTMB-1491-SN, TMB-1491-DS, TMB-1491-S, TMB-2283-K, TMB- 2283 EUDAMEDTMB-1491-DS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932825303209 EUDAMED06932825305920 EUDAMED06932825301830 EUDAMED
- Basic UDI-DI
- 69328253MDR06Q2 EUDAMED69328253MDR05PY EUDAMED69328253TMB1491PE EUDAMED
- Direct Marketing DI
- 06932825305920 EUDAMED
- 510(k) Number
- K131394 FDA 510(k)
- FDA Product Code
- MNW FDA 510(k)
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2770 FDA 510(k)
- Regulation Number
- 870.2770 FDA 510(k)
- Market of Registration
- Poland EUDAMEDGermany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Transtek by Guangdong Transtek Medical Electronics Co., Ltd — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131394 | 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 (4)
- EUDAMED 49c1c192-a1a2-4344-a485-cfbdbe6c8407 61 fields · synced Oct 6, 2026
- FDA 510(k) K131394 24 fields · synced May 18, 2026
- EUDAMED e1c2bce5-e764-40da-9fb4-dbc0230da087 61 fields · synced Jul 15, 2026
- EUDAMED f1c2e3bc-6c65-4af4-bbd4-fcfd8745ea1b 61 fields · synced Jul 19, 2026