FDA Registration
Active
🇷🇺 Russian Federation
YELATMA INSTRUMENT-MAKING ENTERPRISE
Reg #: 3007075140
·
FEI: 3007075140
·
Expires 2026
Products
13
Proprietary Names
9
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- YELATMA INSTRUMENT-MAKING ENTERPRISE
- Registration Number
- 3007075140
- FEI Number
- 3007075140
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25 Yanina Street, Yelatma
- City
- Ryazan Ryazanskaya Oblast'
- Country
- RU
Regulatory Submissions
- 510(k) Number
- K190382
Owner / Operator
- Firm Name
- YELATMA INSTRUMENT-MAKING ENTERPRISE
- Operator Number
- 10026579
- Address
- 25 Yanina Street
- City
- Ryazan
- State
- Ryazanskaya Oblast'
- Postal Code
- 391351
- Country
- RU
US Agent
- Business Name
- Almagia International
- Contact Name
- Yelena Pukhovitskaya
- Address
- 1775 E 18 st, Apt 1E
- City
- BROOKLYN
- State
- NY
- ZIP
- 11229
- Country
- US
- [email protected]
- Phone
- 718 9305152
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2019-12-12 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2009-06-05 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2009-04-21 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2009-06-05 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2010-09-21 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2009-06-05 |
| Urine Transport Kit (Excludes Hiv Testing) | OHZ | Class 1 | Pathology | No | 2009-04-22 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2009-06-05 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2009-02-16 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2009-04-22 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2012-04-03 |
| Urinal | FNP | Class 1 | General Hospital | No | 2009-06-05 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2010-09-22 |
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
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Reprocess Single-Use Device