Data / Medical devices / Lithuania / Esco Medical Technologies, UAB
Esco Medical Technologies, UAB: FDA-registered device maker in Ramuciai Kauno Apskritis, Lithuania, 2 510(k) clearances
Esco Medical Technologies, UAB is registered with the FDA (registration 3009747883) in Ramuciai Kauno Apskritis, Lithuania. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 22, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009747883
- Address
- Gamybos g. 2, Ramuciai Kauno Apskritis, Lithuania, 54468
- Owner or operator
- Esco Medical Technologies, UAB (10041499)
- Roles
- Manufacturer
- First device listed
- May 5, 2014
- Registered through
- 2027
- Brand names listed
- CultureCoin, Esco, MIRI, MIRI Humidity, MIRI II-12, MIRI M (MIRI M-C, MIRI M-D), MIRI TL12, MIRI TL6 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Assisted Reproduction | MQG | 2 | Manufacturer | accessdata.fda.gov |
| Accessory, Assisted Reproduction, Exempt | PUB | 2 | Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 22, 2016 | K151357 | MIRI TL | MQG | Substantially Equivalent | At Medical Uab | accessdata.fda.gov |
| April 23, 2014 | K133742 | XQ-1 INCUBATOR | MQG | Substantially Equivalent | At Medical Uab | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Assisted Reproduction
- All makers of Labware, Assisted Reproduction
- All makers of Accessory, Assisted Reproduction, Exempt
Updated April 22, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.