Tianjin Empecs Medical Device Co., Ltd.
Tianjin, CN
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. appears in FDA device records in Tianjin, CN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Tianjin Empecs Medical Device Co., Ltd. between 2012 and 2017. The busiest year on record is 2017, with 2. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2014 | 1 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162564 | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K152534 | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K133260 | MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K111456 | MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616530 | 3003116995 | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. | NO. 35 and 37, YINGCHENG STREET, HANGU, TIANJIN 300480 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JQPCalculator/Data Processing Module, For Clinical Use
- LFRGlucose Dehydrogenase, Glucose
- CGAGlucose Oxidase, Glucose
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- MQXNeedle, Acupuncture, Single Use
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- NBWSystem, Test, Blood Glucose, Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain