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Sign in to claim this brandINVITROCARE, INCORPORATED
US
Last updated May 25, 2026
What INVITROCARE, INCORPORATED makes
InvitroCare produces media and solutions for in vitro fertilization (IVF) procedures, including culture and washing media for sperm preparation, such as HTF HEPES and SPERM WASH MEDIUM. Their portfolio also includes gradient systems for sperm separation (SPERMCARE Upper and Lower Layer) and specialized reagents like mineral oil for tissue culture and polyvinylpyrrolidone (PVP).
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for reproductive health technologies.
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 InvitroCare, Incorporated manufacture?
InvitroCare specializes in devices used in in vitro fertilization (IVF) procedures. Their primary focus is on media and solutions essential for sperm preparation, such as culture and washing media (e.g., HTF HEPES and SPERM WASH MEDIUM). They also produce gradient systems (like SPERMCARE Upper and Lower Layer) for separating sperm, as well as specialized reagents such as mineral oil for tissue culture and polyvinylpyrrolidone (PVP). These products support critical steps in assisted reproductive technology.
Where is InvitroCare, Incorporated based, and how does this affect its regulatory compliance?
InvitroCare is based in the United States, which means its devices must comply with FDA regulations. Since their products fall under Class II classification, they are subject to specific controls, including mandatory registration, listing, and adherence to quality system requirements. The U.S. regulatory environment ensures these devices meet safety and performance standards for reproductive health applications.
Which regulatory registries list InvitroCare’s devices, and why is this important?
InvitroCare’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides transparent, traceable information about the devices, including their identification, manufacturer details, and classification. For healthcare providers and regulators, this ensures accurate tracking and compliance verification when using or evaluating these products in clinical settings.
How are InvitroCare’s devices classified under regulatory frameworks, and what does this mean for their use?
InvitroCare’s devices are classified as Class II under regulatory frameworks. This classification indicates they pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. For example, these devices may require performance standards, post-market surveillance, or specific labeling requirements to mitigate risks associated with reproductive health procedures.
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
- 190094230
Catalogue (29)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Htf Hepes | 2002-5 | FDA UDI | Class II | Active |
| Sperm Wash Medium | 2005-5 | FDA UDI | Class II | Active |
| SPERMCARE Upper Layer - Gradient System | 2221-100 | FDA UDI | Class II | Active |
| SPERMCARE Upper Layer - Gradient System | 2221-50 | FDA UDI | Class II | Active |
| MINERAL OIL - Oil for Tissue Culture | 2011-5 | FDA UDI | Class II | Active |
| Sperm Wash Medium | 2003 | FDA UDI | Class II | Active |
| Sperm Wash Medium | 2005 | FDA UDI | Class II | Active |
| SPERM WASH MEDIUM for Swim-Up | 2620 | FDA UDI | Class II | Active |
| Sperm Wash Medium | 2003-K2 | FDA UDI | Class II | Active |
| HTF culture medium | 2001 | FDA UDI | Class II | Active |
| PVP - Polyvinylpyrrolidone | 2210 | FDA UDI | Class II | Active |
| SPERMCARE Lower Layer - Gradient System | 2222-50 | FDA UDI | Class II | Active |
| SPERMCARE Lower Layer - Gradient System | 2222-K1 | FDA UDI | Class II | Active |
| SPERM FREEZING MEDIUM - SpermFreeze | 2230 | FDA UDI | Class II | Active |
| Sperm Wash Medium | 2003-K75 | FDA UDI | Class II | Active |
| Human Serum Albumin | 2101 | FDA UDI | Class II | Active |
| SPERMCARE / SPERM WASH - Gradient System | 2224 | FDA UDI | Class II | Active |
| SPERMCARE Lower Layer - Gradient System | 2222-100 | FDA UDI | Class II | Active |
| Sperm Wash Medium | 2003-1 | FDA UDI | Class II | Active |
| Human Serum Albumin | 2101-1 | FDA UDI | Class II | Active |
| Ivc-Two | 2008-V | FDA UDI | Class II | Active |
| IVC-THREE Blastocyst Medium | 2007-V | FDA UDI | Class II | Active |
| Htf Hepes | 2002-L | FDA UDI | Class II | Active |
| MINERAL OIL - Oil for Tissue Culture | 2011 | FDA UDI | Class II | Active |
| Htf Hepes | 2002 | FDA UDI | Class II | Active |
| Sperm Wash Medium | 2005-L | FDA UDI | Class II | Active |
| Hyaluronidse | 2212-10 | FDA UDI | Class II | Active |
| Hyaluronidase | 2212 | FDA UDI | Class II | Active |
| SPERMCARE 100% - Gradient System | 2220-100 | FDA UDI | Class II | Active |
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