FDA Registration
Active
🇯🇵 Japan
ATOM MEDICAL CORPORATION
Reg #: 3005652389
·
FEI: 3004846435
·
Expires 2026
Products
17
Proprietary Names
1
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- ATOM MEDICAL CORPORATION
- Registration Number
- 3005652389
- FEI Number
- 3004846435
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2-2-1, Dojo,
- City
- Sakura-ku, Saitama-shi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K102710
Owner / Operator
- Firm Name
- Atom Medical Corporation
- Operator Number
- 9042398
- Address
- 3-18-15, Hongo
- City
- Bunkyo-ku
- State
- Tokyo
- Postal Code
- 113-0033
- Country
- JP
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Timer, Apgar | LHB | Class 1 | General Hospital | No | 2016-03-17 |
| Incubator, Neonatal | FMZ | Class 2 | General Hospital | No | 2011-01-18 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2006-03-23 |
| Bassinet, Hospital | NZG | Class 2 | General Hospital | No | 2008-11-11 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2010-10-06 |
| Pad, Neonatal Eye | FOK | Class 1 | General Hospital | No | 2010-12-14 |
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2012-04-27 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2006-12-01 |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | Class 2 | Anesthesiology | No | 2011-04-22 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2012-03-26 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2010-09-28 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2012-03-26 |
| Incubator, Neonatal Transport | FPL | Class 2 | General Hospital | No | 2013-05-30 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2015-01-27 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2010-10-06 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2014-11-19 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2011-04-22 |
Proprietary Names
Atom Phototherapy Analyzer II
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device