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Yelatma Instrument-Making Enterprise: FDA-registered device maker in Ryazan Ryazanskaya Oblast', Russia, 1 510(k) clearance

Name: Yelatma Instrument-Making Enterprise FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Yelatma Instrument-Making Enterprise is registered with the FDA (registration 3007075140) in Ryazan Ryazanskaya Oblast', Russia. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 6, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007075140
Address: 25 Yanina Street Yelatma, Ryazan Ryazanskaya Oblast', Russia, 391351
Owner or operator: YELATMA INSTRUMENT-MAKING ENTERPRISE (10026579)
Roles: Exporter to the US, Manufacturer, Reprocessor
First device listed: February 16, 2009
Registered through: 2026
Brand names listed: ALMAG 01 Biofeedback Device, ALMAG 02 Biofeedback Device, ALMAG 03 (DIAMAG) Biofeedback Device, ALMAG ACTIVE Biofeedback Device, ALMAG PLUS Biofeedback Device, POLYMAG Biofeedback Device, ULTRASONIC CLEANING BATH (UZM), ULTRASONIC HYDRODYNAMIC CLEANING MACHINE (UZMM) and more

Devices it lists

Device	Product code	Class	Role	Source
Bedpan	FOB	1	Manufacturer, Reprocessor	accessdata.fda.gov
Blood And Urine Collection Kit (Excludes Hiv Testing)	OIB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Manufacturer	accessdata.fda.gov
Device, Biofeedback	HCC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Manual	LYG	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Tonometer, Ac-Powered	HKX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Urinal	FNP	1	Manufacturer	accessdata.fda.gov
Urine Collection Kit (Excludes Hiv Testing)	OIE	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Urine Transport Kit (Excludes Hiv Testing)	OHZ	1	Manufacturer, Reprocessor	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
December 6, 2019	K190382	Intraocular Pressure Tonometer EASYTON	HKX	Substantially Equivalent	Company Elamed	accessdata.fda.gov

Compare with other makers

Updated December 6, 2019. 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.