Data / Medical devices / China / Tianjin Huahong Technology Co., Ltd.
Tianjin Huahong Technology Co., Ltd.: FDA-registered device maker in Tianjin, China, 11 510(k) clearances
Tianjin Huahong Technology Co., Ltd. is registered with the FDA (registration 3009498536) in Tianjin, China. It lists 7 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 10, 2026. Registered through 2027. FDA data exported November 3, 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
- 3009498536
- Address
- A01, Plant B, No 278, Hangkong Road,Tianjin Pilot Free Trade Zone (Air Port Industrial Park), Tianjin, China, 300308
- Owner or operator
- Tianjin Huahong Technology Co., Ltd. (10038941)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 15, 2021
- Registered through
- 2027
- Brand names listed
- CareLiving, CareTouch Lancet, CareTouch Lancing Device, Diska Nulife Lancing Device, Diska Nulife Single Use Lancets 30G, Dynarex, FORA SAFETY LANCET-ROUND(Sterile), GLUCOPAD TC SMART +Lancets and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Surgical, Clip | GDO | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 10, 2026 | K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | FMI | Substantially Equivalent | Hh Global Technology, Inc. | accessdata.fda.gov |
| January 6, 2026 | K252886 | Pen Needle | FMI | Substantially Equivalent | Hh Global Technology, Inc. | accessdata.fda.gov |
| December 9, 2025 | K253706 | Lancing device (HH-XV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| November 15, 2024 | K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-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, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| June 20, 2024 | K241627 | Safety Lancet (XXXV) | FMK | Substantially Equivalent | Tianjin Huahong Technology 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 |
| July 1, 2022 | K221176 | Insulin Pen Needle | FMI | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| May 19, 2022 | K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | FMK | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| May 17, 2022 | K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | FMK | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| November 12, 2021 | K202319 | Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) | FMI | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| May 11, 2017 | K162566 | AIK Sterile Acupuncture Needles for Single Use | MQX | Substantially Equivalent | Changchun Aik Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Applier, Surgical, Clip
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Needle, Acupuncture, Single Use
Updated August 10, 2026. 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.