Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007075140

FEI Number

3007075140

Entity Name

YELATMA INSTRUMENT-MAKING ENTERPRISE

City/State/Country

Ryazan Ryazanskaya Oblast', RU

Establishment Address

25 Yanina Street, Yelatma, Ryazan Ryazanskaya Oblast' 391351, RU

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

YELATMA INSTRUMENT-MAKING ENTERPRISE (Owner Number: 10026579)

Owner / Operator Contact Address

25 Yanina Street, Ryazan, RU-RYA 391351, RU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ULTRASONIC CLEANING BATH (UZM) ULTRASONIC HYDRODYNAMIC CLEANING MACHINE (UZMM) Urine collection kit ALMAG PLUS Biofeedback Device ALMAG 01 Biofeedback Device POLYMAG Biofeedback Device ALMAG 02 Biofeedback Device ALMAG ACTIVE Biofeedback Device ALMAG 03 (DIAMAG) Biofeedback Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2019-12-12
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2009-06-05
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2009-04-21
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2009-06-05
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2010-09-21
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2009-06-05
OHZ	Urine Transport Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2009-04-22
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2009-06-05
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2009-02-16
FOB	Bedpan	General Hospital	Class 1	880.6730	2009-04-22
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2012-04-03
FNP	Urinal	General Hospital	Class 1	880.6730	2009-06-05
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2010-09-22

Official Correspondent

No official correspondent registered.

US Agent Details

Yelena Pukhovitskaya Business: Almagia International Email: info@almagia.com Phone: (718) 9305152

Related Public Records

Same Entity

YELATMA INSTRUMENT-MAKING ENTERPRISE

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K870750	Keeler Instruments, Inc.	KEELER PULSAIR NON CONTACT TONOMETER	1987-03-17
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007075140. Last updated year: 2026. Please use registration number 3007075140 when referencing this establishment in official correspondence.