Tianjin Rilifine Medical Device Co., Ltd.
Registered establishment in Tianjin, China. 3 device types, 2 clearances.
Tianjin Rilifine Medical Device Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Multiple Use Blood Lancet For Single Patient Use Only, Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature and 1 other device type. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | TIANJIN RILIFINE MEDICAL DEVICE CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021314645 |
| FEI number | 3021314645 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 天津云帆医疗器械有限公司 |
|---|---|
| Unified social credit code | 91120113MA07967H28 |
| Source | NMPA UDI database |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | No 32, Jingguan Road, Yixingbu, Beichen District |
| Postal code | 300402 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | Class 2 | Specification: 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G, Lancing device, Disposable Sterile Lancet: Twist Lancet; Model I; | 2022 | 21 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | Lancet,Blood lancets,Lancing device,Lancet device,Safety lancet,Twist lancet, Specification: 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G, Disposable Sterile Lancet: Safety Lancet; Model II; | 2021 | 36 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | Specification: 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G, Lancing device, Disposable Sterile Lancet: Twist Lancet; Model I; | 2022 | 21 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222246 | 2022-11-21 | QRL | Traditional | This company |
| K222055 | 2022-11-15 | FMK | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 4000 ㎡ |
|---|---|
| Main products | Twist lancets, Safety lancets, Lancing devices |
| Certifications | ISO 13485, Korea GMP, US FDA, NMPA |
| Export markets | China, USA, Korea, Brazil, South Asia, 69+ countries |
| OEM and ODM | Offered |
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.
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