FDA Registration
Active
🇨🇳 China
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD
Reg #: 3011420269
·
FEI: 3011420269
·
Expires 2026
Products
10
Proprietary Names
70
Establishment Types
3
Classifications
10
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD
- Registration Number
- 3011420269
- FEI Number
- 3011420269
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Zone A, No.105, Dongli Road, Torch Development District
- City
- Zhongshan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K172141
Owner / Operator
- Firm Name
- Guangdong Transtek Medical Electronics Co.,Ltd
- Operator Number
- 10048437
- Address
- Zone A, No.105 ,Dongli Road,, Torch Development District
- City
- Zhongshan
- State
- Guangdong
- Postal Code
- 528437
- Country
- CN
- Correspondent
- Jerry Fan
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3557 158th St Flushing
- City
- Auburndale
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 14102 ext. 964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-06-11 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-07-09 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2022-09-04 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2025-09-09 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2023-11-14 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2025-12-22 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2025-12-22 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2025-12-22 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2023-01-04 |
| Oximeter, Wellness | PGJ | Class 2 | Cardiovascular | No | 2025-06-20 |
Proprietary Names
Blood Pressure Monitor,Model : TMB-2296-BT,TMB-2296-B
Trakr Healthcare Smart Blood Pressure Monitor, Model: TMB-2296-B
Easy@Home Blood Pressure Monitor,Model : EBP-96B
Blood Pressure Monitor: TMB-2084-T,TMB-2084-A
PSW01
Metene Blood Pressure Monitor, Model:TMB-1117-SN; HYLOGY Blood Pressure Monitor,Model: LS810-S
iProven Blood Pressure Monitor, model: BPM-337
Blood Pressure Monitor,Model: TMB-1598-S
Renpho Blood Pressure Monitor , Model: R-J004;Renpho Blood Pressure Monitor , Model: RP-BPM001
Lifehood digital blood pressure monitor, Model:TMB-1491-S
Meraw Blood Pressure Monitor Irregular Heartbeat Monitoring, Model Number LS808-S
Renpho Blood Pressure Monitor , Model: TMB-1872-T
Blood Pressure Monitor , Model: TMB-1491-BS
GRANZIA Automatic Blood Pressure Monitor,Model: TMB-995-S , TMB-1585-S
Easy@Home Blood Pressure Monitor, Model : EBP-095
GLAMOR Blood Pressure Monitor, Model: TMB-1490-CS , TMB-1873
Etekcity Smart Blood Pressure Monitor, Model :TMB-1583-BS
1 BY ONE Bluetooth Blood Pressure Monitor Model:703NA-0005; TMB-1585-BT
Blood Pressure Monitor,model: ABP-2088-T
Blood Pressure Monitor,Model : TMB-2080-K,TMB-2088, TMB-2083; Blood Pressure Monitor,Model :51-1490
Easy@Home Blood Pressure Monitor,Model: EBP-08B
VILIBRUN Blood Pressure Monitor, Model :BM1585
Renpho Smart Blood Pressure Monitor , Model:TMB-1872-B
Dario Smart Blood Pressure Monitor Gen 2, Model :1217-05
Renpho Smart Blood Pressure Monitor , Model:RP-BPM001S
EZFAST Blood Pressure Monitor,Model : TMB-2080-K
Meraw Blood Pressure Monitor Irregular Heartbeat Monitoring, Dual Users, Model Number: TMB-2088-C
BPM-35
Blood Pressure Monitor,Model:BBZ32-AA01,BBZ32-CA01,BBZ32-AB01,BBZ32-BA01,BBZ32-BB01,BBZ32-DB01,BBZ32-DA01
Pulse Body Fat Analyzer,Model:GBF-2008-B
TeleRPM Body Fat Analyzer,Model:GBF-2008-B
TeleRPM Blood Pressure Monitor ,Model :TMB-2092-Ga
B200
Hearing Aids; Common Name: Linner Nova-lite; Model: Nova
Wrist Blood Pressure Monitor,Model:TMB-1581-ZY
Blood Pressure Monitor,Model:BWZ51,BWZ52
Blood Pressure Monitor,Model:TMB-2285-BT,TMB-2285-BK
Wrist Blood Pressure Monitor, Model:TMB-988-S
Blood Pressure Monitor, Model:TMB-1117-SN
Withings BPM Vision, Model: WPM07, REF: WPM07-08
Withings BPM Pro 2, Model: WPM07, REF: WPM07-07
Withings BPM Pro 2,Model:WPM07
Blood pressure monitor TMB-2287-B
Hilo Cuff
Aktiia Init I1
LifeHood Blood Pressure Monitor ,Model :TMB-2085
Easy@Home Wrist Blood Pressure Monitor, Model: EBP-085 ; Easy@Home Wrist Blood Pressure Monitor,Model: TMB-2085
Meraw Wrist Blood Pressure Monitor Irregular Heartbeat Monitoring, Model Number: TMB-2085-K
Blood Pressure Monitor, Model : TMB-2283,TMB-2283-K
Blood Pressure Monitor, Model : TMB-1776-ZY
Blood Pressure Monitor, Model: BBY36-BT1, BBY36-1
Blood Pressure Monitor,Model : 51-1490
Blood Pressure Monitor,Model : TMB-2266
32nd Street Media Blood Pressure Monitor, Model: TMB-2284-B
Meraw Blood Pressure Monitor lrregular Heartbeat Monitoring, Model Number :TMB-2084
Checkme Blood Pressure Monitor,Model:BP3-C1,BP3-C2
Blood Pressure Monitor, Model : BBY31-BT1,BBY31-1
Blood Pressure Monitor, Model : TMB-2271-BK
Blood Pressure monitor, Model: TMB-1873, TMB-1490-CS
Transtek Blood Pressure Monitor, Model: TMB-2273-B, TMB-2273-BT
Ovutek Arm Blood Pressure Monitor,Model: VBP443
Blood Pressure Monitor ,Model :TMB-2084-KT
Blood Pressure Monitor, Model : TMB-2276-B,TMB-1583-S,TMB-1583-BS
Blood Pressure Monitor, Model : TMB-2284, TMB-2284-BT, TMB-2284-B, TMB-2284-T, TMB-2284-BTK,TMB-2276-BT
Blood Pressure Monitor, Model : TMB-2288,TMB-2288-BT,TMB-2288-B,TMB-2288-C
Pulse Blood Pressure Monitor,Model:BB2284-AE01
Blood pressure monitor, Model: BB2284-AE01
Veridian Cellular BPM, Model : 210-2111C
Blood Pressure Monitor, Model: BB1597-G
TeleRPM Gen2 Blood Glucose Monitoring System, Model: BGM 2280-A
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)