Tianjin Huahong Technology Co., Ltd.
Tianjin, CN
Tianjin Huahong Technology Co., Ltd. appears in FDA device records in Tianjin, CN. FDA records list 14 510(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 14 510(k) clearances for Tianjin Huahong Technology Co., Ltd. between 2021 and 2026. The busiest year on record is 2022, with 4. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 4 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260845 | Huahong Sharps Container (HHR-I, HHR-II) | MMK | Substantially Equivalent | |
| K262211 | Lancet | QRL | Substantially Equivalent | |
| K260191 | Safety lancet (XXXVII) | FMK | Substantially Equivalent | |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | FMK | Substantially Equivalent | |
| K253706 | Lancing device (HH-XV-T) | QRL | Substantially Equivalent | |
| K251694 | safety lancet | FMK | Substantially Equivalent | |
| 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 | |
| K241627 | Safety Lancet (XXXV) | FMK | Substantially Equivalent | |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | FMK | Substantially Equivalent | |
| 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 | |
| K221176 | Insulin Pen Needle | FMI | Substantially Equivalent | |
| K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | FMK | Substantially Equivalent | |
| K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | FMK | Substantially Equivalent | |
| K202319 | Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009498536 | 3009498536 | Tianjin Huahong Technology Co., Ltd. | A01, Plant B, No 278, Hangkong Road,Tianjin Pilot Free Trade Zone (Air Port Industrial Park), Tianjin 300308 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GDOApplier, Surgical, Clip
- MMKContainer, Sharps
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- MQXNeedle, Acupuncture, Single Use
- FMINeedle, Hypodermic, Single Lumen
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
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