Data / Medical devices / China / Tianjin Empecs Medical Device Co., Ltd.
Tianjin Empecs Medical Device Co., Ltd.: FDA-registered device maker in Tianjin, China, 8 510(k) clearances
Tianjin Empecs Medical Device Co., Ltd. is registered with the FDA (registration 9616530) in Tianjin, China. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 4, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9616530
- FEI number
- 3003116995
- Address
- NO. 35 and 37, YINGCHENG STREET, HANGU BINHAI NEW AREA, Tianjin, China, 300480
- Owner or operator
- TIANJIN EMPECS MEDICAL DEVICE CO., LTD. (9047576)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 16, 2007
- Registered through
- 2027
- Brand names listed
- Allevy Glucose Control Solution, Allevy Lancet, Allevy Lancing Device, Allevy MM1100 Blood Glucose Meter, Allevy MM1100 Blood Glucose Monitoring System, Allevy MM1100 Blood Glucose Test Strip, CX11B1, CareLiving Glucose Control Solution and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Manufacturer | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Exporter to the US | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 4, 2024 | K232330 | Lancing System | QRK | Substantially Equivalent | Ningbo Medsun Medical Co., Ltd. | accessdata.fda.gov |
| November 21, 2022 | K222246 | Disposable Sterile Lancet | QRL | Substantially Equivalent | Tianjin Rilifine Medical Device Co., Ltd. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| June 7, 2017 | 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 | Tianjin Empecs Medical Device Co., Ltd. | accessdata.fda.gov |
| March 21, 2017 | 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 | Tianjin Empecs Medical Device Co., Ltd. | accessdata.fda.gov |
| June 27, 2014 | K133260 | MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Tianjin Empecs Medical Device Co., Ltd. | accessdata.fda.gov |
| February 28, 2012 | K111456 | MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Tianjin Empecs Medical Device Co., Ltd. | accessdata.fda.gov |
| February 28, 2001 | K002827 | MAC ACUPUNCTURE NEEDLE | MQX | Substantially Equivalent | Haenglim Seowon Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose Dehydrogenase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Oxidase, Glucose
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Updated January 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.