Compumedics L T D

FDA Filings

This page includes the latest FDA filings for Compumedics L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

AUSTRALIA

AUSTRALIAN STOCK EXCHANGE

CMP

DUNS 753750967

FDA Registration(s)

• Registration Number: 3004752776
• FEI Number: 3004752776
• Name: Rene van de Zande
• Owner & Operator: COMPUMEDICS LIMITED
• Contact Address: 30-40 FLOCKHART STREET --; ABBOTSFORD, VICTORIA AU-NOTA 3067 AU
• US Agent:
  • Rene van de Zande
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 9613619
• FEI Number: 3004674371
• Name: COMPUMEDICS LIMITED
• Owner & Operator: Compumedics
• Contact Address: 30-40 Flockhart Street, Abbotsford,; Melbourne AU-VIC Victoria 3067 AU
• Official Correspondent:
  • William Alam
  • 061-3-84207300-x
• US Agent:
  • Steven Johnson
  • Compumedics USA Ltd
  • 704 7493200 5
  • 704 7493299
  • steve.johnson@compumedicsusa.com
• Importing Logistics Registration:
  • Importer: COMPUMEDICS USA, INC.
  • Address: 5015 W WT HARRIS BLVD STE E ; Charlotte, NC 28269 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 30-40 Flockhart Street, Abbotsford,; Melbourne Victoria, 3067 AU
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 09342451002228 COMPUMEDICS LIMITED	Compumedics Okti 8029-0004-01	2023-06-21
GUDID 09342451002211 COMPUMEDICS LIMITED	Compumedics Okti 8029-0003-01	2023-06-21
GUDID 09342451002204 COMPUMEDICS LIMITED	Compumedics Okti 8029-0002-01	2023-06-21
GUDID 09342451001924 COMPUMEDICS LIMITED	Compumedics Grael 9028-0020-01	2021-04-27
GUDID 09342451001917 COMPUMEDICS LIMITED	Compumedics Grael 7028-0008-01	2021-04-27
GUDID 09342451001894 COMPUMEDICS LIMITED	Compumedics Grael 9028-0023-01	2021-04-27
GUDID 09342451001870 COMPUMEDICS LIMITED	Compumedics Grael 8028-0100-02	2021-04-27
GUDID 09342451001863 COMPUMEDICS LIMITED	Compumedics 8028-0022-01	2021-04-27
GUDID 09342451001856 COMPUMEDICS LIMITED	Compumedics 8022-0063-01	2021-04-27
GUDID 09342451001849 COMPUMEDICS LIMITED	Compumedics 7028-0006-02	2021-04-27
GUDID 09342451001832 COMPUMEDICS LIMITED	Compumedics Grael 9028-0010-01	2021-04-27
GUDID 09342451001825 COMPUMEDICS LIMITED	Compumedics Grael 9028-0004-02	2021-04-27
GUDID 09342451001771 COMPUMEDICS LIMITED	Compumedics Grael 9028-0002-02	2021-04-27
GUDID 09342451001764 COMPUMEDICS LIMITED	Compumedics Somte 7012-0015-01	2021-04-27
GUDID 09342451001757 COMPUMEDICS LIMITED	Compumedics Somte 8012-0008-05	2021-04-27
GUDID 09342451001740 COMPUMEDICS LIMITED	Compumedics Somte 8012-0007-02	2021-04-27
GUDID 09342451001733 COMPUMEDICS LIMITED	Compumedics Somte 9012-0003-01	2021-04-27
GUDID 09342451001580 COMPUMEDICS LIMITED	Compumedics SynAmps RT 8032-0002-01	2021-04-27
GUDID 09342451001573 COMPUMEDICS LIMITED	Compumedics SynAmps RT 9032-0002-01	2021-04-27
GUDID 09342451001566 COMPUMEDICS LIMITED	Compumedics SynAmps RT 8032-0001-01	2021-04-27
GUDID 09342451001559 COMPUMEDICS LIMITED	Compumedics SynAmps RT 9032-0001-01	2021-04-27
GUDID 09342451001542 COMPUMEDICS LIMITED	Compumedics SynAmps RT 8032-0003-01	2021-04-27
GUDID 09342451001535 COMPUMEDICS LIMITED	Compumedics SynAmps RT 9032-0003-01	2021-04-27
GUDID 09342451001528 COMPUMEDICS LIMITED	Compumedics SynAmps RT 8021-0004-01	2021-04-27
GUDID 09342451001511 COMPUMEDICS LIMITED	Compumedics SynAmps RT 00081300	2021-04-27
GUDID 09342451001504 COMPUMEDICS LIMITED	Compumedics SynAmps RT 9021-0002-01	2021-04-27
GUDID 09342451001498 COMPUMEDICS LIMITED	Compumedics Somte 7023-0006-01	2021-04-27
GUDID 09342451001481 COMPUMEDICS LIMITED	Compumedics Somte 7023-0005-01	2021-04-27
GUDID 09342451001474 COMPUMEDICS LIMITED	Compumedics Somte 7023-0003-02	2021-04-27
GUDID 09342451001467 COMPUMEDICS LIMITED	Compumedics 7000-0270-00	2021-04-27
GUDID 09342451001382 COMPUMEDICS LIMITED	Compumedics Somte 8023-0001-02	2021-04-27
GUDID 09342451001368 COMPUMEDICS LIMITED	Compumedics Somte 9023-0002-01	2021-04-27
GUDID 09342451001313 COMPUMEDICS LIMITED	Compumedics Grael 9028-0009-01	2021-04-27
GUDID 09342451001306 COMPUMEDICS LIMITED	Compumedics Grael 8028-0007-01	2021-04-27
GUDID 09342451001290 COMPUMEDICS LIMITED	Compumedics Grael 9028-0008-01	2021-04-27
GUDID 09342451001283 COMPUMEDICS LIMITED	Compumedics Grael 8028-0008-01	2021-04-27
GUDID 09342451001276 COMPUMEDICS LIMITED	Compumedics Grael 9028-0001-02	2021-04-27
GUDID 09342451001269 COMPUMEDICS LIMITED	Compumedics Grael 8028-0001-02	2021-04-27
GUDID 09342451001252 COMPUMEDICS LIMITED	Compumedics Grael 9028-0003-02	2021-04-27
GUDID 09342451001245 COMPUMEDICS LIMITED	Compumedics Grael 8028-0003-01	2021-04-27
GUDID 09342451001238 COMPUMEDICS LIMITED	Compumedics Grael 8028-0002-02	2021-04-27
GUDID 09342451001207 COMPUMEDICS LIMITED	Compumedics Neuvo 3122-0001-01	2021-04-27
GUDID 09342451001184 COMPUMEDICS LIMITED	Compumedics Neuvo 4722-0035-01	2021-04-27
GUDID 09342451001177 COMPUMEDICS LIMITED	Compumedics Neuvo 9022-0009-01	2021-04-27
GUDID 09342451001160 COMPUMEDICS LIMITED	Compumedics Neuvo 3300-0143-00	2021-04-27
GUDID 09342451001153 COMPUMEDICS LIMITED	Compumedics Neuvo 4622-0005-01	2021-04-27
GUDID 09342451001146 COMPUMEDICS LIMITED	Compumedics Neuvo 4722-0029-01	2021-04-27
GUDID 09342451001139 COMPUMEDICS LIMITED	Compumedics Neuvo 4722-0028-01	2021-04-27
GUDID 09342451001122 COMPUMEDICS LIMITED	Compumedics Neuvo 4722-0031-01	2021-04-27
GUDID 09342451001115 COMPUMEDICS LIMITED	Compumedics Neuvo 4722-0033-01	2021-04-27
GUDID 09342451001108 COMPUMEDICS LIMITED	Compumedics Neuvo 4722-0034-01	2021-04-27
GUDID 09342451001092 COMPUMEDICS LIMITED	Compumedics Neuvo 8022-0005-01	2021-04-27
GUDID 09342451001085 COMPUMEDICS LIMITED	Compumedics Neuvo 8022-0004-01	2021-04-27
GUDID 09342451001078 COMPUMEDICS LIMITED	Compumedics Neuvo 8022-0001-01	2021-04-27
GUDID 09342451001061 COMPUMEDICS LIMITED	Compumedics Neuvo 9022-0008-01	2021-04-27
GUDID 09342451001054 COMPUMEDICS LIMITED	Compumedics Neuvo 9022-0004-01	2021-04-27
GUDID 09342451001047 COMPUMEDICS LIMITED	Compumedics Neuvo 9022-0002-01	2021-04-27
GUDID 09342451001030 COMPUMEDICS LIMITED	Compumedics Neuvo 8022-0018-02	2021-04-27
GUDID 09342451001023 COMPUMEDICS LIMITED	Compumedics Neuvo 8022-0011-01	2021-04-27
GUDID 09342451001016 COMPUMEDICS LIMITED	Compumedics Neuvo 9022-0013-01	2021-04-27
PMN K191785 | OLY COMPUMEDICS LIMITED [Compumedics]	Orion LifeSpan MEG	2020-02-18
PMN K191785 Compumedics Limited	Orion LifeSpan MEG	2020-02-14
PMN K093223 | OLZ COMPUMEDICS LIMITED [Compumedics]	Compumedics Grael System	2010-12-16
PMN K093223 | OLV COMPUMEDICS LIMITED [Compumedics]	Compumedics Grael System	2010-12-16
PMN K093223 | GWQ COMPUMEDICS LIMITED [Compumedics]	Compumedics Grael System	2010-12-16
PMN K093223 COMPUMEDICS LIMITED	COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG	2010-01-15
PMN K955841 | MNR COMPUMEDICS LIMITED [Compumedics]	Compumedics Sleep Monitoring System	2008-11-17
PMN K955841 | MNR COMPUMEDICS LIMITED [Compumedics]	Compumedics Sleep Monitoring System S-series	2008-11-17
PMN K072201 | MNR COMPUMEDICS LIMITED [Compumedics]	Compumedics Somte PSG System	2008-11-17
PMN K040194 | MNR COMPUMEDICS LIMITED [Compumedics]	Compumedics Summit IP	2008-11-17
PMN K021176 | MNR COMPUMEDICS LIMITED [Compumedics]	Compumedics Somte System	2008-11-17
PMN K003175 | OLV COMPUMEDICS LIMITED [Compumedics]	Compumedics Siesta System	2008-11-17
PMN K003175 | GWQ COMPUMEDICS LIMITED [Compumedics]	Compumedics Siesta System	2008-11-17
PMN K000068 | OLT COMPUMEDICS LIMITED [Compumedics]	Compumedics E-series Sleep System	2008-11-17
PMN K000068 | GWQ COMPUMEDICS LIMITED [Compumedics]	Compumedics E-series Sleep System	2008-11-17
PMN K072201 COMPUMEDICS LIMITED	COMPUMEDICS SOMTE PSG RECORDING SYSTEM	2008-04-14
PMN K051085 | IYN Rene van de Zande [COMPUMEDICS LIMITED]	Multi-Dop Xdigital	2007-02-09
PMN K051085 | IYN Rene van de Zande [COMPUMEDICS LIMITED]	Multi-Dop Xdigital (+CO2)	2007-02-09
PMN K051085 | IYN Rene van de Zande [COMPUMEDICS LIMITED]	Multi-Dop Tdigital	2007-02-09
PMN K051085 | IYN Rene van de Zande [COMPUMEDICS LIMITED]	Multi-Dop Tdigital (+CO2)	2007-02-09
PMN K051085 | IYN Rene van de Zande [COMPUMEDICS LIMITED]	Doppler-BoxX	2007-02-09
PMN K051085 | IYN Rene van de Zande [COMPUMEDICS LIMITED]	Doppler-BoxX1	2007-02-09
PMN K051085 | ITX Rene van de Zande [COMPUMEDICS LIMITED]	Multi-Dop Xdigital	2007-02-09
PMN K051085 | ITX Rene van de Zande [COMPUMEDICS LIMITED]	Multi-Dop Xdigital (+CO2)	2007-02-09
PMN K051085 | ITX Rene van de Zande [COMPUMEDICS LIMITED]	Multi-Dop Tdigital	2007-02-09
PMN K051085 | ITX Rene van de Zande [COMPUMEDICS LIMITED]	Multi-Dop Tdigital (+CO2)	2007-02-09
PMN K051085 | ITX Rene van de Zande [COMPUMEDICS LIMITED]	Doppler-BoxX	2007-02-09
PMN K051085 | ITX Rene van de Zande [COMPUMEDICS LIMITED]	Doppler-BoxX1	2007-02-09
PMN K021176 COMPUMEDICS LIMITED	COMPUMEDICS SOMTE SYSTEM	2003-01-21
PMN K003175 COMPUMEDICS LIMITED	COMPUMEDICS SIESTA SYSTEM	2000-12-27

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