Sinurep
Breast localization needle mod. SINUREP 20G X 100 mm
3manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Ningbo Hysent Medical Technology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 13 |
Record
| Listed by | Medax Srl Unipersonale, Italy |
|---|---|
| FDA product code | MIJ |
| Device type | Needle, Tumor Localization |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2018-04-10 |
| Record revised | 2026-06-08 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SR20120-03 | In distribution | |
| SR20100-02 | In distribution | |
| SR20080-00 | In distribution | |
| SR20080-03 | In distribution | |
| SR20120-00 | In distribution | |
| SR20100-00 | In distribution | |
| SR20080-02 | In distribution | |
| SR20120-02 | In distribution | |
| SR20100-03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kopans | Cook Incorporated | 27 |
| Medwire | Medax Srl Unipersonale | 22 |
| ALM SET | H.S. Hospital Service SPA | 6 |
| Cook | Cook Incorporated | 5 |
| Tuflex | Somatex Medical Technologies GmbH | 4 |
| Breast Needle Locator | Remington Medical, Inc. | 4 |
| Q-Wire System | Somatex Medical Technologies GmbH | 3 |
| Tuloc Premium | Somatex Medical Technologies GmbH | 3 |
| Tuloc | Somatex Medical Technologies GmbH | 3 |
| Tuflex Premium | Somatex Medical Technologies GmbH | 3 |
| MRI Tuloc | Somatex Medical Technologies GmbH | 2 |
| Duo System Stereo | Somatex Medical Technologies GmbH | 2 |
Showing 12 of 37. All products under Needle, Tumor Localization
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.