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Sign in to claim this brandVitrolife Sweden AB
US
Last updated May 23, 2026
What Vitrolife Sweden AB makes
The company manufactures single-use medical devices for assisted reproduction and laboratory procedures, including micropipettes for intracytoplasmic sperm injection (ICSI) and oocyte biopsy, as well as disposable vacuum tubing for fluid transfer. It also produces IVF media, aspiration needles for follicle retrieval, and consumables like vitrification carriers, centrifuge tubes, and procedure dishes designed for in vitro fertilization workflows.
The portfolio includes Class I and Class II devices, with regulatory submissions filed under the FDA’s 510(k) and Unique Device Identification (UDI) programs. These products are intended for use in reproductive medicine and laboratory settings, adhering to U.S. regulatory requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Vitrolife Sweden AB manufacture?
Vitrolife Sweden AB specializes in single-use medical devices primarily for assisted reproduction and laboratory procedures. Their portfolio includes user-induced micropipettes (such as ICSI and biopsy pipettes), IVF oocyte aspiration needles, IVF media and media kits, vitrification carriers, centrifuge tubes, procedure dishes, and disposable vacuum tubing. These devices are designed to support workflows in in vitro fertilization (IVF) and related reproductive medicine applications.
Where is Vitrolife Sweden AB based, and what regulatory regions do their devices target?
Vitrolife Sweden AB is based in the United States, though the company name reflects its origins in Sweden. Their devices are regulated under U.S. authorities, as evidenced by submissions through the FDA’s 510(k) pathway and Unique Device Identification (UDI) program. This indicates compliance with U.S. regulatory requirements for medical devices.
Which regulatory registries or databases list Vitrolife Sweden AB’s devices?
Vitrolife Sweden AB’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identification (UDI) database. These registries track medical devices that have undergone premarket notification (510(k)) clearance or UDI assignment, ensuring traceability and compliance with U.S. regulatory standards.
How are Vitrolife Sweden AB’s devices classified under U.S. regulations?
Vitrolife Sweden AB’s devices fall into Class I and Class II classifications under U.S. regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification is determined by factors like the device’s intended use, potential risks, and regulatory history.
What is the primary purpose of Vitrolife Sweden AB’s IVF-related products?
Vitrolife Sweden AB’s IVF-related products are engineered to streamline and enhance assisted reproduction procedures. For example, their ICSI pipettes and biopsy pipettes facilitate precise sperm injection and oocyte handling, while follicle aspiration sets and oocyte aspiration needles enable safe retrieval of eggs during IVF. Other products, like IVF media kits and vitrification carriers, support embryo culture and cryopreservation, ensuring optimal conditions for reproductive success in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 631805488
Catalogue (410)
Page 8 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cyst Puncture Needle with Stylet | 14803 | FDA UDI | Class II | Unknown |
| Holding Pipette | 15308 | FDA UDI | Class II | Active |
| Hyase-10x | 10183 | FDA UDI | Class II | Unknown |
| ICSI Pipette | 15653 | FDA UDI | Class II | Active |
| Hatching Pipette | 14324 | FDA UDI | Class II | Unknown |
| ICSI Pipette | 14349 | FDA UDI | Class II | Unknown |
| Blastomere Biosy Pipette | 14336 | FDA UDI | Class II | Unknown |
| Vacuum Pump Tubing | 17203 | FDA UDI | Class II | Active |
| Holding Pipette | 15309 | FDA UDI | Class II | Active |
| Collection Dish 90 mm | 16007 | FDA UDI | Class II | Active |
| ICSI Pipette | 15432 | FDA UDI | Class II | Active |
| Handling Pipette | 15532 | FDA UDI | Class II | Active |
| ICSI Pipette | 15410 | FDA UDI | Class II | Active |
| Holding Pipette | 15335 | FDA UDI | Class II | Active |
| Vacuum Pump Tubing | 17201 | FDA UDI | Class II | Active |
| ICSI Pipette | 15349 | FDA UDI | Class II | Active |
| PZD Pipette | 15527 | FDA UDI | Class II | Active |
| PZD Pipette | 15669 | FDA UDI | Class II | Active |
| Follicle Aspiration Set, Double Lumen | 14114 | FDA UDI | Class II | Unknown |
| Follicle Aspiration Set, Double Lumen | 14105 | FDA UDI | Class II | Unknown |
| Biopsy Pipette | 15149 | FDA UDI | Class II | Active |
| Holding Pipette | 14393 | FDA UDI | Class II | Unknown |
| Spermfreeze Solution | K113786 | FDA 510(k) | Class II | Active |
| G-Sperm, Model 10032 | K022247 | FDA 510(k) | Class II | Active |
| Rapid-I Kit | K140207 | EUDAMEDFDA 510(k) | Class II | Active |
| Perfadex Solution For Organ Preservation | K000881 | FDA 510(k) | Class II | Active |
| G-Oocyte | K032877 | FDA 510(k) | Class II | Active |
| G-Pgd | K033101 | FDA 510(k) | Class II | Active |
| G-Rinse, Model 10031 | K022295 | FDA 510(k) | Class II | Active |
| Ultra RapidWarm™ Blast | K240605 | FDA 510(k) | Class II | Active |
| FreezeKit Cleave , ThawKit Cleave | K150950 | FDA 510(k) | Class II | Active |
| G-Mm, Model 10038 | K021894 | FDA 510(k) | Class II | Active |
| Rapid-i™ Kit | K181461 | FDA 510(k) | Class II | Active |
| G-2 Version 3, Model 10049 | K021890 | FDA 510(k) | Class II | Active |
| G-1 Version 3, Model 10048 | K022244 | FDA 510(k) | Class II | Active |
| Asp-100, Model 2100 | K991345 | FDA 510(k) | Class II | Active |
| RapidVit™ Oocyte, RapidWarm™ Oocyte | K183486 | FDA 510(k) | Class II | Active |
| Follicle Aspiration Set, Reduced Single Lumen | K172050 | FDA 510(k) | Class II | Active |
| G-Ivf G5 Series | K081116 | FDA 510(k) | Class II | Active |
| Follicle Aspiration Set, Reduced Single Lumen | K082727 | FDA 510(k)FDA UDI | Class II | Active |
| G-1 V5 | K081114 | FDA 510(k) | Class II | Active |
| Gx-IVF, Gx-TL, Gx-MOPS PLUS | K202862 | FDA 510(k) | Class II | Active |
| Follicle Aspiration Set | K161970 | FDA 510(k) | Class II | Active |
| G-Mops, Model 10030 | K021893 | FDA 510(k) | Class II | Active |
| Rapidvit And Rapidwarm Cleave | K080446 | FDA 510(k) | Class II | Active |
| Icsi-100 | K043116 | FDA 510(k) | Class II | Active |
| Perfadex With Tham | K081997 | FDA 510(k) | Class II | Active |
| Hsa-Solution, Model 10034/10064 | K021896 | FDA 510(k) | Class II | Active |
| Ultrasound Transducer Cover | K241662 | FDA 510(k) | Class II | Active |
| Embryoglue | K031015 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Vitrolife Sweden Ab Vastra Frolunda Vastra Gotaland · SE FEI 3003995932