Atom Medical Corp

FDA Filings

This page includes the latest FDA filings for Atom Medical Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005652389
• FEI Number: 3004846435
• Name: Atom Medical Urawa Factory
• Owner & Operator: ATOM MEDICAL CORPORATION
• Contact Address: 3-18-15 HONGO --; BUNKYO-KU JP-13 Tokyo 113-0033 JP
• Official Correspondent:
  • Kenichi - Shimada
  • 81-3-38152941-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • usagent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2-1, Dojo 2-chome ; Sakura-ku Saitama, 338-0835 JP
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
GUDID 14942962603864 ATOM MEDICAL CORPORATION	Patient Circuit 60386	2019-01-29
GUDID 04942962684484 ATOM MEDICAL CORPORATION	Atom Phototherapy Analyzer Ⅱ 68448	2019-01-29
GUDID 04942962616461 ATOM MEDICAL CORPORATION	Weight Monitor Unit 61646	2019-01-29
GUDID 04942962616409 ATOM MEDICAL CORPORATION	Weight Monitor Unit 61640	2019-01-29
GUDID 04942962616331 ATOM MEDICAL CORPORATION	Atom Infant Warmer 103 AC120V 61633	2019-01-29
GUDID 04942962616263 ATOM MEDICAL CORPORATION	SpO2 Unit(Nellcor) 61626	2019-01-29
GUDID 04942962616256 ATOM MEDICAL CORPORATION	SpO2 Unit(Masimo) 61625	2019-01-29
GUDID 04942962616225 ATOM MEDICAL CORPORATION	SpO2 Unit(Nellcor) 61622	2019-01-29
GUDID 04942962616218 ATOM MEDICAL CORPORATION	SpO2 Unit(Masimo) 61621	2019-01-29
GUDID 04942962616195 ATOM MEDICAL CORPORATION	Suction Canister, 500mL For S401D 61619	2019-01-29
GUDID 04942962616157 ATOM MEDICAL CORPORATION	Weight Monitor Unit(w/NAWI Verification) 61615	2019-01-29
GUDID 04942962616072 ATOM MEDICAL CORPORATION	Atom Infant Incubator 101 AC120V w/o O2 Controll 61607	2019-01-29
GUDID 04942962616058 ATOM MEDICAL CORPORATION	Atom Infant Incubator 101 AC120V w/O2 Controller 61605	2019-01-29
GUDID 04942962616027 ATOM MEDICAL CORPORATION	Atom Infant Incubator 100 AC120V w/o O2 Controller 61602	2019-01-29
GUDID 04942962616003 ATOM MEDICAL CORPORATION	Atom Infant Incubator 100 AC120V w/O2 Controller U 61600	2019-01-29
GUDID 04942962615778 ATOM MEDICAL CORPORATION	Sunflower Warmer, Wall Mount AC120V 61577	2019-01-29
GUDID 04942962615761 ATOM MEDICAL CORPORATION	Sunflower Warmer, Stand AC120V 61576	2019-01-29
GUDID 04942962615747 ATOM MEDICAL CORPORATION	Sunflower Warmer, Wall Mount AC120V 61574	2019-01-29
GUDID 04942962615723 ATOM MEDICAL CORPORATION	Sunflower Warmer, Stand AC120V 61572	2019-01-29
GUDID 04942962615228 ATOM MEDICAL CORPORATION	V-808 Main Unit Only(120 V) 61522	2019-01-29
GUDID 04942962613057 ATOM MEDICAL CORPORATION	V-707 with Power Pack(100-120V) 61305	2019-01-29
GUDID 04942962609944 ATOM MEDICAL CORPORATION	Resuscitation Unit P type 60994	2019-01-29
GUDID 04942962609937 ATOM MEDICAL CORPORATION	Resuscitation Unit E type 60993	2019-01-29
GUDID 04942962609920 ATOM MEDICAL CORPORATION	Blender Unit E type 60992	2019-01-29
GUDID 04942962609913 ATOM MEDICAL CORPORATION	Blender Unit P type 60991	2019-01-29
GUDID 04942962609821 ATOM MEDICAL CORPORATION	Resuscitation Unit 104 E type (Stand-alone type) 60982	2019-01-29
GUDID 04942962608916 ATOM MEDICAL CORPORATION	Connecting Cable(W) For Dispo Skin Temp Probe 60891	2019-01-29
GUDID 04942962608909 ATOM MEDICAL CORPORATION	Dispo Skin Temp Probe(W) (10 pcs/box) 60890	2019-01-29
GUDID 04942962608855 ATOM MEDICAL CORPORATION	Connecting Cable(Y) For Dispo Skin Temp Probe 60885	2019-01-29
GUDID 04942962608848 ATOM MEDICAL CORPORATION	Dispo Skin Temp Probe(Y) (10 pcs/box) 60884	2019-01-29
GUDID 04942962608831 ATOM MEDICAL CORPORATION	Skin Temp Probe, 5mm O.D.(Y) 60883	2019-01-29
GUDID 04942962608824 ATOM MEDICAL CORPORATION	Skin Temp Probe, 10mm O.D.(Y) 60882	2019-01-29
GUDID 04942962608817 ATOM MEDICAL CORPORATION	Skin Temp Probe, 5mm O.D.(W) 60881	2019-01-29
GUDID 04942962608800 ATOM MEDICAL CORPORATION	Skin Temp Probe, 10mm O.D.(W) 60880	2019-01-29
GUDID 04942962608619 ATOM MEDICAL CORPORATION	Semi-Iris Access Port Cover(20 pcs/pkg) 60861	2019-01-29
GUDID 04942962608602 ATOM MEDICAL CORPORATION	Access Port Cover(20 pcs/pkg) 60860	2019-01-29
GUDID 04942962608596 ATOM MEDICAL CORPORATION	Oxygen Sensor For Dual Incu i, Incu i, V-2200/2100 60859	2019-01-29
GUDID 04942962603874 ATOM MEDICAL CORPORATION	Neo Cot HL Stand 60387	2019-01-29
GUDID 04942962603775 ATOM MEDICAL CORPORATION	BILI-THERAPY Spot type / Mount Type AC100-240V 60377	2019-01-29
GUDID 04942962603744 ATOM MEDICAL CORPORATION	Pad Cover(S) For BILI-THERAPY Pad Type(50 pcs/box) 60374	2019-01-29
GUDID 04942962603737 ATOM MEDICAL CORPORATION	Pad Cover(L) For BILI-THERAPY Pad Type(50 pcs/box) 60373	2019-01-29
GUDID 04942962603720 ATOM MEDICAL CORPORATION	Pad(S) For BILI-THERAPY Pad Type 60372	2019-01-29
GUDID 04942962603713 ATOM MEDICAL CORPORATION	Pad(L) For BILI-THERAPY Pad Type 60371	2019-01-29
GUDID 04942962603706 ATOM MEDICAL CORPORATION	BILI-THERAPY Pad Type 60370	2019-01-29
GUDID 04942962603669 ATOM MEDICAL CORPORATION	CPR Timer 60366	2019-01-29
GUDID 04942962603638 ATOM MEDICAL CORPORATION	Resusci Flow w/Blender/Rail mounting type 60363	2019-01-29
GUDID 04942962603621 ATOM MEDICAL CORPORATION	Resusci Flow Rail mounting type 60362	2019-01-29
GUDID 04942962603614 ATOM MEDICAL CORPORATION	BILI-THERAPY Spot Type / Arm Type For F-Rail AC100 60361	2019-01-29
GUDID 04942962603607 ATOM MEDICAL CORPORATION	BILI-THERAPY Spot Type / Stand Type AC100-240V 60360	2019-01-29
GUDID 04942962603553 ATOM MEDICAL CORPORATION	Dispo Liner, 500mL For S401D, Suction Canister(30 60355	2019-01-29
GUDID 04942962603379 ATOM MEDICAL CORPORATION	Neo Sheets(100 pcs/box) 60337	2019-01-29
GUDID 04942962603218 ATOM MEDICAL CORPORATION	Mattress Sheets(5 pcs/pkg) 60321	2019-01-29
GUDID 04942962603171 ATOM MEDICAL CORPORATION	Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-8 60317	2019-01-29
GUDID 04942962603058 ATOM MEDICAL CORPORATION	Oxygen Sensor For V-808 60305	2019-01-29
GUDID 04942962602983 ATOM MEDICAL CORPORATION	Test Bag, 50mL 60298	2019-01-29
GUDID 04942962602693 ATOM MEDICAL CORPORATION	Pneumoclean Electrostatic Filter(5 pcs/pkg) 60269	2019-01-29
GUDID 04942962602167 ATOM MEDICAL CORPORATION	Infa Lite AC100-240V 60216	2019-01-29
GUDID 04942962601467 ATOM MEDICAL CORPORATION	Face Mask For Infant(20 pcs/box) 60146	2019-01-29
GUDID 04942962601450 ATOM MEDICAL CORPORATION	Face Mask For Neonatal(20 pcs/box) 60145	2019-01-29
GUDID 04942962261227 ATOM MEDICAL CORPORATION	Mattress Sheet for Neo Cot(5 pcs/pkg) 26122	2019-01-29
JJQ Atom Medical Urawa Factory [ATOM MEDICAL CORPORATION]	Atom Phototherapy Analyzer II	2014-11-19
PMN K123937 ATOM MEDICAL CORPORATION	ATOM TRANSCAPSULE V-707	2013-05-23
PMN K120937 ATOM MEDICAL CORPORATION	SUNFLOWER WARNER	2012-07-06
PMN K111547 ATOM MEDICAL CORPORATION	BILI-THERAPY PAD TYPE	2012-04-12
PMN K103317 ATOM MEDICAL CORPORATION	RESUSCITATION UNIT 105	2011-04-20
PMN K102542 ATOM MEDICAL CORPORATION	RESUSCI FLOW; RESUSCI FLOW 104	2011-04-06
PMN K103828 ATOM MEDICAL CORPORATION	BILI-THERAPY SPOT TYPE	2011-03-29
PMN K102227 ATOM MEDICAL CORPORATION	INFA WARMER I	2011-01-21
PMN K102226 ATOM MEDICAL CORPORATION	DUAL INCU I	2011-01-04
PMN K102279 ATOM MEDICAL CORPORATION	INCU I	2010-12-29
PMN K102710 ATOM MEDICAL CORPORATION	NEO-SERVO I	2010-12-22
PMN K021809 ATOM MEDICAL CORP.	V-2100G ADVANCED INFANT INCUBATOR	2002-07-18
PMN K002355 ATOM MEDICAL CORP.	ATOM INFA WARMER V-505	2000-10-10

Related Finance Registrations

NCAGE Code	SGR88	ATOM MEDICAL CORPORATION
NCAGE Code	S5206	ATOM MEDICAL CORPORATION
CAGE Code	S5206	ATOM MEDICAL CORPORATION
CAGE Code	SGR88	ATOM MEDICAL CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009216271	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE: 9018.90, 9019.20, 9027.50	126 CTN
2020081514597	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,3926.90,	189 CTN
2020081516314	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	LITHIUM ION BATTERIES CONTAINED IN EQUIPMENT HS CODE 850760	3 CAS
2020081015222	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,9027.50	101 CTN
2020081015222	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,9027.50	101 CTN
202007227244	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,8507.60, 9402.90,8529.90	263 CTN
202007227244	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,8507.60, 9402.90,8529.90	263 CTN
202006298253	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE:8423.10,9018.90	198 CTN
2020050413018	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	LITHIUM ION BATTERIES CONTAINED IN EQUIPMENT HS CODE 850760	8 CAS
2020050411357	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS CODE:9018.90,9027.50,9019.20,	175 CTN