Tianjin Huahong Technology Co., Ltd.
Manufacturer and brand owner in Tianjin, China. 6 device types, 30 products catalogued, 15 clearances.
Tianjin Huahong Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Applier, Surgical, Clip, Needle, Acupuncture, Single Use and 4 other device types. 30 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009498536 |
| FEI number | 3009498536 |
| DUNS | 421272490 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 天津华鸿科技股份有限公司 |
|---|---|
| Unified social credit code | 911201165661306999 |
| Source | NMPA UDI database |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | A01, Plant B, No 278, Hangkong Road,Tianjin Pilot Free Trade Zone (Air Port Industrial Park) |
| Postal code | 300308 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applier, Surgical, Clip | Class 1 | Huahong | 2024 | 9 |
| Multiple Use Blood Lancet For Single Patient Use Only | Class 2 | iHealth, TeleRPM Single Use Lancets 30G, Greater Goods Single Use Lancets 30G, Diska Nulife Lancing Device, Greater Goods Lancing Device, VivaGuard Lancets and 16 more | 2022 | 21 |
| Needle, Acupuncture, Single Use | Class 2 | 2025 | 33 | |
| Needle, Hypodermic, Single Lumen | Class 2 | Huahong, Dynarex, MedtFine, medt, PEN Tips, Medt – Fine Insulin Pen Needle (Safety Type) | 2021 | 71 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | FORA SAFETY LANCET-ROUND(Sterile), TD-5052 AKTIVSAFE LANCET(Sterile), Standard, Huahong, Medilet | 2022 | 36 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | iHealth, TeleRPM Single Use Lancets 30G, Greater Goods Single Use Lancets 30G, Diska Nulife Lancing Device, Greater Goods Lancing Device, VivaGuard Lancets and 15 more | 2022 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Care Touch | QRL | 10 |
| Huahong | FMK | 5 |
| Huahong | QRL | 5 |
| Care Touch | QRK | 3 |
| GoodLife | QRL | 3 |
| LinkSun | QRL | 2 |
| Pro Comfort | QRL | 2 |
| VivaGuard | QRL | 2 |
| metene | QRL | 2 |
| Medhome | QRL | 2 |
| HMD | QRL | 2 |
| leraise | QRL | 1 |
| Sinocare | QRL | 1 |
| Glucoracyik | QRL | 1 |
| ReliOn | QRL | 1 |
| QikDiag | FMI | 1 |
| Glucoracy | QRL | 1 |
| Allevy | QRL | 1 |
| Huahong | QRK | 1 |
| BKG | FMI | 1 |
| Lite Touch | QRL | 1 |
| AuQty | FMI | 1 |
| CareTouch | QRL | 1 |
| Bionime | QRL | 1 |
| LinkSun | FMK | 1 |
| huahong | FMI | 1 |
| GlucoDr. | QRL | 1 |
| Advocate | FMK | 1 |
| Seren Guard | FMI | 1 |
| standard | FMK | 1 |
Clearances
15 clearances name Tianjin Huahong Technology Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K262135 | 2026-08-18 | QRL | Traditional | This company |
| K260845 | 2026-08-05 | MMK | Traditional | This company |
| K262211 | 2026-07-22 | QRL | Special | This company |
| K260191 | 2026-03-31 | FMK | Traditional | This company |
| K252490 | 2026-02-12 | FMK | Special | This company |
| K253706 | 2025-12-09 | QRL | Special | This company |
| K251694 | 2025-06-26 | FMK | Special | This company |
| K243306 | 2024-11-15 | QRL | Special | This company |
| K241627 | 2024-06-20 | FMK | Traditional | This company |
| K240806 | 2024-05-21 | FMK | Traditional | This company |
| K220475 | 2022-07-06 | QRL | Traditional | This company |
| K221176 | 2022-07-01 | FMI | Special | This company |
| K220370 | 2022-05-19 | FMK | Traditional | This company |
| K220372 | 2022-05-17 | FMK | Traditional | This company |
| K202319 | 2021-11-12 | FMI | Traditional | This company |
| K252886 | 2026-01-06 | FMI | Traditional | Hh Global Technology, Inc. |
| K162566 | 2017-05-11 | MQX | Traditional | Changchun AIK Medical Devices Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | Safety lancets, Twist lancets, Lancing devices, Heel stick lancets, Insulin pen needles |
| Certifications | China CGMP, Korea KGMP, EN ISO 13485:2016, Canada CMDCAS, CE, UL CFR Part 820, FDA, Canada product registration |
| Export markets | 100+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.