NovoSort
A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including,…
A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device. The NovoSort is a component designed to facilitate isolation of sperm while in the ProteX. Case of 10
Who Else Makes It
Concentrated in Guangdong (5), Hubei (1), Sichuan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Boomingshing Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Guangzhou Pinzhi Medical Device Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 5 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| UKS Medical Technology (Chongqing) Co., Ltd. | Chongging | Sichuan | Contract manufacturer | 4 |
Record
| Listed by | RSI Technology Group, LLC, United States |
|---|---|
| FDA product code | PUD |
| Device type | Labware, Assisted Reproduction, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6160 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-23 |
| Record revised | 2026-02-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | In distribution | ||
| 1 | 10 | In distribution | |
| 1 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 12 |
| Metiec | Wuhan Huchuang Union Technology Co., Ltd. | 10 |
| SFG Sperm CD | Spectrum Fertility Group Inc. | 3 |
| Kitazato ReproPlate-K1(3Well) | Kitazato Corporation | 2 |
| Kitazato ReproPlate-K2 | Kitazato Corporation | 2 |
| Kitazato ReproPlate-K6 | Kitazato Corporation | 2 |
| Nunc IVF Multidish 4 Well Nunclon | Nunc A/S | 2 |
| Astec IVF 4Well Dish | Astec Co., Ltd. | 2 |
| Kitazato ReproPlate-K3 | Kitazato Corporation | 2 |
| SFG Sperm Collection Container | Spectrum Fertility Group Inc. | 1 |
| V-CULTUREDISH-60 | Vitromed GmbH | 1 |
| V-Sperm Morpho Slide | Vitromed GmbH | 1 |
Showing 12 of 52. All products under Labware, Assisted Reproduction, Exempt
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.