Anhui Tiankang Medical Technology Co., Ltd.
Manufacturer and brand owner in Tianchang, Anhui, China. 9 device types, 6 products catalogued, 12 clearances.
Anhui Tiankang Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Syringe, Antistick and 7 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2012.
9device types registered with the FDA
6products catalogued under its own name
12510(k) clearances
Registration
| Registered name | ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007590959 |
| FEI number | 3007590959 |
| DUNS | 527035248 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 安徽天康医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 9134110071990801XY |
| Source | NMPA UDI database |
Location
| City | Tianchang |
|---|---|
| Province | Anhui |
| Address | No 228, WeiYi Road |
| Postal code | 239300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Allergen And Vaccine Delivery Needles | Class 2 | Bifurcated needle | 2023 | 4 |
| Dispenser, Liquid Medication | Class 1 | Fluid Dispensing Connector | 2012 | 86 |
| Enteral Syringes With Enteral Specific Connectors | Class 2 | Oral/Enteral Syringes with ENFit connector (12ml to 60ml), low dose tip Oral/ Enteral syringes | 2015 | 13 |
| Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 | Feeding tube | 2023 | 17 |
| Needle, Hypodermic, Single Lumen | Class 2 | TK safety needle, Sterile Disposable Needle; Sterile Disposable Safety Needle; Sterile Disposable Syringe;, Sterile Disposable Syringe with Needle; Sterile Disposable Syringe with Safety Needle | 2020 | 71 |
| Saline, Vascular Access Flush | Class 2 | Prefilled syringe | 2023 | 10 |
| Set, Administration, Intravascular | Class 2 | I.V. administration set, Disposable infusion set with needle; Disposable infusion set without needle; Disposable infusion set with safety needle, IV Set with needle; IV set without needle; IV set with safety needle; IV set DEHP-Free, Infusion set with latex; infusion set latex free | 2017 | 49 |
| Syringe, Antistick | Class 2 | Safety insulin syringe, Disposable syringe with permanently attached needle, safety syringe with permanently attached needle, TK insulin syringe, safety insulin with/without retractable needle | 2014 | 39 |
| Syringe, Piston | Class 2 | Sterile Disposable Syringe; Sterile Disposable Syringe with Needle; Sterile Disposable Syringe with Safety Needle, Sterile Disposable Needle; Sterile Disposable Safety Needle;, Safety insulin syringe, Disposable syringe with permanently attached needle, safety syringe with permanently attached needle, TK insulin syringe, safety insulin with/without retractable needle | 2013 | 60 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Tkmd | FMI | 150 |
| Tkmd | FMF | 46 |
| MedZon Health | FMI | 2 |
| Metier | FMF | 2 |
| 420STOCK | FMF | 2 |
| MedZon Health | FMF | 1 |
Clearances
12 clearances name Anhui Tiankang Medical Technology Co., Ltd. as applicant. 1 is held by another company 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 |
|---|---|---|---|---|
| K222773 | 2023-08-17 | PIF | Traditional | This company |
| K222772 | 2023-08-17 | PNR | Traditional | This company |
| K230756 | 2023-08-12 | NGT | Traditional | This company |
| K222385 | 2022-12-06 | SCL | Traditional | This company |
| K220204 | 2022-07-14 | FMF | Traditional | This company |
| K212368 | 2021-10-24 | FXX | Traditional | This company |
| K210464 | 2021-08-24 | FMF | Traditional | This company |
| K191639 | 2020-09-11 | MEG | Traditional | This company |
| K191640 | 2020-08-26 | FPA | Traditional | This company |
| K191644 | 2020-08-06 | FMI | Traditional | This company |
| K191642 | 2020-01-06 | FMF | Traditional | This company |
| K191643 | 2019-12-19 | FMI | Traditional | This company |
| K131531 | 2014-05-12 | MEG | Traditional | Anhui Tiankang Medical Products Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1999 |
|---|---|
| Employees | 1,100 |
| Factory area | 50,000+ square meters |
| Main products | Safety syringes, Auto-disable syringes, IV sets, Blood transfusion sets, Medical needles |
| Certifications | CE, ISO 13485, WHO-PQS, FDA 510K |
| Export markets | Europe, Africa, Latin America |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Anhui Ares Medical Technology Co., Ltd. | 28 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | 18 |
| Anhui Kangda Medical Products Co., Ltd. | 7 |
| Tianchang Jiarui Packaging Material Co., Ltd. | 7 |
| Anhui Medfaith Medical Devices Co., Ltd. | 6 |
| SLK Medical Material (Tianchang) Co., Ltd. | 4 |
| Tianchang Roujie Brushing Industry Co., Ltd. | 2 |
| Anhui Tianyang Pharmaceutical Co., Ltd. | 1 |
| Anhui Newtoshi Cleaning Products Co., Ltd. | 1 |
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.