SpermFilter Ready-to-Use Gradient 80% USA
SpermFilter® Ready-to-use gradients USA (80% and 45%) are ready to use gradient systems for semen preparation. The SpermFilter® Ready-to-use system can be used for semen preparation for…
SpermFilter® Ready-to-use gradients USA (80% and 45%) are ready to use gradient systems for semen preparation. The SpermFilter® Ready-to-use system can be used for semen preparation for Intra Uterine Insemination (IUI), In Vitro Fertilization (IVF) and IntraCytoplasmatic Sperm Injection (ICSI).
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | Gynotec B.V., Netherlands |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Repacker / relabeller |
| 510(k) | K053494 |
| Record published | 2026-01-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Keep away from sunlight |
| Packaging | Box, box of 5 |
| Sizes | Total volume 10 to 250 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPF80-USA-0100 | Total Volume 100 ml | In distribution |
| SPF80-USA-0050 | Total Volume 50 ml | In distribution |
| SPF80-USA-0250 | Total Volume 250 ml | In distribution |
| SPF80-USA-0010 | Total Volume 10 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LifeGlobal® Media | LifeGlobal Group, LLC | 93 |
| Sydney IVF | William A. Cook Australia PTY, Ltd. | 29 |
| LifeGlobal® Media | Coopersurgical, Inc. | 27 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 22 |
| Nidacon | Nidacon International AB | 19 |
| Sil-Select Plus Lower Layer | Fertipro NV | 8 |
| FertiCult Mineral Oil | Fertipro NV | 8 |
| Dewin | Donnevie Medical Technology (Shanghai) Co., Ltd. | 8 |
| SpermGrad | Vitrolife Sweden AB | 8 |
| Sequential Culture Media | Kitazato Corporation | 8 |
| Sperm Wash Medium | Invitrocare Inc | 7 |
| Enhance-S Plus | Vitrolife Inc. | 7 |
Showing 12 of 360. All products under Media, Reproductive
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.