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Sign in to claim this brandORIGIO INC.
US
Last updated May 23, 2026
What ORIGIO INC. makes
The company produces microtools and vitrification carriers designed for assisted reproduction procedures. These include devices like the CRYOPETTE, a container for cryopreservation, and the STRIPPER, a tool for follicle aspiration and oocyte retrieval.
The portfolio consists of Class II medical devices, authorised through FDA pathways including the 510(k) and UDI requirements. These products are listed under the US regulatory framework and are manufactured by a company 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 Origio Inc. manufacture?
Origio Inc. specialises in devices used within assisted reproduction procedures. Their portfolio includes assisted reproduction microtools, such as the STRIPPER (used for follicle aspiration and oocyte retrieval), and assisted reproduction vitrification carriers, like the CRYOPETTE (a container for cryopreserving biological samples). These tools are designed to support fertility treatments by enabling precise handling and preservation of reproductive cells.
Where is Origio Inc. based, and how does that affect its regulatory standing?
Origio Inc. is headquartered in the United States. As a US-based manufacturer, its devices are authorised under the FDA’s regulatory framework. The company’s products fall under Class II classification, which typically requires compliance with 510(k) premarket notifications and UDI (Unique Device Identification) requirements to demonstrate safety and effectiveness for their intended use in assisted reproduction.
Which regulatory registries or databases list Origio Inc.’s devices?
Origio Inc.’s devices are listed in the FDA’s 510(k) database and comply with FDA UDI (Unique Device Identification) requirements. These registries ensure transparency about the devices’ authorised status, intended use, and compliance with US regulatory pathways. The inclusion in these databases reflects the company’s adherence to FDA-mandated processes for Class II medical devices.
How are Origio Inc.’s devices classified under regulatory frameworks?
Origio Inc.’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. Class II devices like those produced by Origio must undergo 510(k) premarket submissions to demonstrate substantial equivalence to legally marketed predicates, ensuring they meet regulatory requirements for assisted reproduction tools.
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
- 787068394
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cryopette | CRY-PETTE-GOLD | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-275 | FDA UDI | Class II | Active |
| Stripper | MXL3-275 | FDA UDI | Class II | Active |
| Stripper | MXL3-50 | FDA UDI | Class II | Active |
| Cryopette | CRY-PETTE-MULTI | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-150 | FDA UDI | Class II | Active |
| Cryopette | CRY-PETTE-RED | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-75 | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-CC | FDA UDI | Class II | Active |
| Stripper | MXL3-125 | FDA UDI | Class II | Active |
| Cryopette | CRY-PETTE-BLUE | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-100 | FDA UDI | Class II | Active |
| Stripper | MXL3-100 | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-135 | FDA UDI | Class II | Active |
| Stripper | MXL3-STR-PGD | FDA UDI | Class II | Active |
| Stripper | MXL3-600 | FDA UDI | Class II | Active |
| Stripper | MXL3-STR-CGR | FDA UDI | Class II | Active |
| Stripper | MXL3-STR | FDA UDI | Class II | Active |
| Stripper | MXL3-STR-PGD-CG | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-125 | FDA UDI | Class II | Active |
| Stripper | MXL3-135 | FDA UDI | Class II | Active |
| Stripper | MXL3-175 | FDA UDI | Class II | Active |
| Stripper | MXL3-150 | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-200 | FDA UDI | Class II | Active |
| Stripper | MXL3-STR-CC | FDA UDI | Class II | Active |
| Stripper | MXL3-75 | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-175 | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-600 | FDA UDI | Class II | Active |
| Cryopette | CRY-PETTE-BLACK | FDA UDI | Class II | Active |
| Stripper | MXL3-IND-50 | FDA UDI | Class II | Active |
| Stripper | MXL3-CC | FDA UDI | Class II | Active |
| Stripper | MXL3-200 | FDA UDI | Class II | Active |
| Origio Gas Line Filter | K132870 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Origio Inc. has one FDA recall record initiated on June 20, 2014, which is listed with a terminated status. The recall was due to a reported identification of packaging breach involving the nylon pouch sterile barrier for the 3-pack configuration.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 20, 2014 | Z-1946-2014 | — | terminated | Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration |