SpermFilter Stock Solution 100% USA
SpermFilter® Stock Solution 100% USA is a stocksolution for semen preparation. It is an isotonic gradient for semen preparation with a density of approximately 1.12 g/ml. SpermFilter® Stock…
SpermFilter® Stock Solution 100% USA is a stocksolution for semen preparation. It is an isotonic gradient for semen preparation with a density of approximately 1.12 g/ml. SpermFilter® Stock Solution 100% USA can be used for semen preparation for Intra Uterine Insemination (IUI), In Vitro Fertilization (IVF) and IntraCytoplasmatic Sperm Injection (ICSI). SpermFilter® Stock Solution 100% USA is used during assisted reproductive Technology (ART) procedures of patients and couples undergoing infertility treatments.
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 |
| Sizes | Total volume 50 to 250 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPF100-USA-0100 | Total Volume 100 ml | In distribution |
| SPF100-USA-0050 | Total Volume 50 ml | In distribution |
| SPF100-USA-0250 | Total Volume 250 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.