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Sign in to claim this brandWhat KITAZATO CORPORATION makes
Kitazato Corporation manufactures single-use and reusable devices for assisted reproduction, including intrauterine insemination (IUI) catheters, oocyte aspiration needles, biopsy micropipettes, and vitrification carriers for embryo preservation. Their product line also covers IVF medium kits and sterile biopsy procedure kits for non-medicated soft-tissue sampling, as well as vitrification carriers designed for cryopreservation of oocytes and embryos.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
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 Kitazato Corporation primarily manufacture?
Kitazato Corporation specializes in devices used for assisted reproduction and related procedures. Their product line includes single-use and reusable items like intrauterine insemination (IUI) catheters, oocyte aspiration needles for IVF, micropipettes for biopsy and embryo manipulation, vitrification carriers for cryopreservation, and sterile kits for IVF media and soft-tissue biopsy procedures. These devices are designed to support fertility treatments and embryo handling in clinical settings.
Where is Kitazato Corporation based, and what does that mean for regulatory oversight?
Kitazato Corporation is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies all of Kitazato’s listed devices as Class II, which typically requires premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution. This classification reflects moderate risk, requiring additional scrutiny compared to Class I devices.
Are Kitazato Corporation’s devices listed in any regulatory databases, and why does that matter?
Yes, Kitazato Corporation’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This listing is critical for traceability, post-market surveillance, and compliance tracking. The UDI system assigns a unique product identifier to each device, enabling healthcare providers, regulators, and manufacturers to track devices throughout their lifecycle, ensuring transparency in supply chains and facilitating recalls or safety alerts if needed.
How are Kitazato Corporation’s devices classified by the FDA, and what does that classification imply?
The FDA classifies all of Kitazato Corporation’s listed devices as Class II. This classification indicates that while the devices pose a moderate risk, they are not considered high-risk like Class III devices. Class II devices generally require premarket submissions (such as 510(k) clearances) to demonstrate safety and effectiveness compared to existing, legally marketed devices. The classification ensures that these products undergo rigorous review to balance innovation with patient safety in assisted reproduction and related procedures.
What kinds of procedures or treatments are Kitazato Corporation’s devices used for?
Kitazato Corporation’s devices are primarily used in assisted reproductive technologies (ART) and fertility treatments. Their products support procedures like intrauterine insemination (IUI) with catheters, in vitro fertilization (IVF) through oocyte aspiration needles and biopsy micropipettes, embryo manipulation, and cryopreservation of oocytes and embryos using vitrification carriers. The company also provides sterile kits for IVF media and non-medicated soft-tissue biopsy procedures, catering to the precise needs of fertility clinics and reproductive medicine.
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
- 711091157
Catalogue (288)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kitazato ET Catheter Type1-v1 EC-PRO Normal | 215018 Type1-v1 EC-PRO Normal | FDA UDI | Class II | Active |
| Kitazato ET Catheter Type2-v1 EC-PRO Supported | 215118 Type2-v1 EC-PRO Supported | FDA UDI | Class II | Active |
| Sepa Sperm 40% | Sepa Sperm 40% | FDA UDI | Class II | Active |
| Kitazato Injection Micropipette | MT-INJ-2S55-30 | FDA UDI | Class II | Active |
| Sperm Fridge | Sperm Fridge | FDA UDI | Class II | Active |
| Ultra-Fast Vitri | VT601USUF-4 | FDA UDI | Class II | Active |
| BS(Basic Solution) Pack 4 vials | VT601US-BSx4 | FDA UDI | Class II | Active |
| Kitazato OPU Needle with Connection Tube, Type2-v13 | 359354 Type2-v13 | FDA UDI | Class II | Active |
| Sequential Culture Media | Sequential Culture Media | FDA UDI | Class II | Active |
| Kitazato OPU Needle with Connection Tube, Type2-v15 | 350304 Type2-v15 | FDA UDI | Class II | Active |
| Kitazato ET Catheter | 224332 | FDA UDI | Class II | Active |
| Kitazato OPU Needle | 382023 | FDA UDI | Class II | Active |
| ET Catheter | ET Catheter | FDA UDI | Class II | Active |
| Kitazato ET Catheter | 275328 | FDA UDI | Class II | Active |
| Kitazato OPU Needle Type2-v2 | 357354 Type2-v2 | FDA UDI | Class II | Active |
| ES(Equilibration Solution) Pack 4 vials 4ml | VT601US-ES4x4 | FDA UDI | Class II | Active |
| Kitazato Injection Micropipette | MT-INJ-1S45-35 | FDA UDI | Class II | Active |
| Hypure Oil Light 50mL | MOLH-50 | FDA UDI | Class II | Active |
| Kitazato Injection Micropipette | MT-INJ-1S55-35 | FDA UDI | Class II | Active |
| Cryotop US(R) | Cryotop US(R) | FDA UDI | Class II | Active |
| Kitazato Injection Micropipette | MT-INJ-1L55-35 | FDA UDI | Class II | Active |
| Kitazato Injection Micropipette | MT-INJ-2L55-35 | FDA UDI | Class II | Active |
| CryotopCL(G) | CryotopCL(G) | FDA UDI | Class II | Active |
| CryotopUS-flash(Y) | CryotopUS-flash(Y) | FDA UDI | Class II | Active |
| Kitazato OPU Needle with Connection Tube, Type2-v16 | 351304 Type2-v16 | FDA UDI | Class II | Active |
| TS(Thawing Solution) | VT602US-TS | FDA UDI | Class II | Active |
| CryotopCL(B) | CryotopCL(G) | FDA UDI | Class II | Active |
| Vitrification Kit (W) | VT601US-TOP(W) | FDA UDI | Class II | Active |
| Kitazato OPU Needle Type2-v5 | 350354 Type2-v5 | FDA UDI | Class II | Active |
| Vitrification Media(BS solution) | VT601US | FDA UDI | Class II | Active |
| Kitazato Injection Micropipette | MT-INJ-1L50-35 | FDA UDI | Class II | Active |
| Thawing Media | VT602US | FDA UDI | Class II | Active |
| PBS(-) Phosphate buffered saline 100mL | PBSF-100 | FDA UDI | Class II | Unknown |
| Sepa Sperm Wash Solution | Sepa Sperm Wash Solution | FDA UDI | Class II | Active |
| ES(Equilibration Solution) | VT601US-ES | FDA UDI | Class II | Active |
| CryotopUS-scoop(R) | CryotopUS-scoop(R) | FDA UDI | Class II | Active |
| Kitazato Injection Micropipette | MT-INJ-1L55-30 | FDA UDI | Class II | Active |
| Kitazato OPU Needle Type2-v5 | 350304 Type2-v5 | FDA UDI | Class II | Active |
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