Origio Inc.

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Origio Inc. is a medical device manufacturer, with 300 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II) and 1 FDA recall as of 14 Nov 2026.

Devices: 300
FDA recalls: 1

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries: FDA GUDID 299
EUDAMED 5
FDA 510(k) 1

A device listed in two registries counts in both.
Device classes: FDA Class II 300
FDA recalls: 1 recall matched by name
Identifiers: DUNS 787068394

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue300

Newest first, rows 1-50 of 300

Search and filter all 300 devices

Rows 1-50 of 300

Showing 1-50 of 300

Company details

DUNS number: 787068394

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by ORIGIO INC., initiated on 2014-06-20. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

2014
- 20 Jun 2014 Z-1946-2014 Class II Terminated Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration Distribution: Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France,…
  Full distribution text
  Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.
  Submission number: K000915

Frequently asked questions

How many devices does ORIGIO INC. have in the registry?

The registry currently lists 300 devices for ORIGIO INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ORIGIO INC.'s devices?

Among its 50 most recently registered devices, ORIGIO INC. has devices listed in FDA GUDID (50 devices).

What risk classes do ORIGIO INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for ORIGIO INC.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for ORIGIO INC.?

FDA recall records list 1 recall initiated by ORIGIO INC., the most recent initiated on 20 Jun 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from ORIGIO INC. in the registry?

The most recently registered devices listed for ORIGIO INC. include MPH-MED-45, MBB-FP-SM-20, CRYOPETTE CRY-PETTE-GOLD and MDP-140-0.

Generated automatically from registry data and not verified by a human reviewer.