Ontex Bvba

FDA Filings

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

FDA Registration(s)

• Registration Number: 9615100
• FEI Number: 3001019699
• Name: Amy L. Brown
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• US Agent:
  • Amy L. Brown
  • Valor Brands LLC
  • 770 3469250 207
  • amy.brown@ontexglobal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 960 North Point Parkway, Suite 100 ; Alpharetta, GA 30005 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3010220314
• FEI Number: 3010220314
• Name: PRODUCTOS INTERNACIONALES MABE SA DE CV
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• US Agent:
  • Amy L. Brown
  • Valor Brands LLC
  • 770 3469250 207
  • amy.brown@ontexglobal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Calle 12 Norte #105 Ciudad Industrial Otay; Tijuana Baja California, 22444 MX
• Establishment Type: Manufacture Medical Device

• Registration Number: 3003500682
• FEI Number: 3003500682
• Name: Amy L. Brown
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• US Agent:
  • Amy L. Brown
  • Valor Brands LLC
  • 770 3469250 207
  • amy.brown@ontexglobal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 960 North Point Parkway, Suite 100 ; Alpharetta, GA 30005 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 9617256
• FEI Number: 3003081218
• Name: Amy L. Brown
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• US Agent:
  • Amy L. Brown
  • Valor Brands LLC
  • 770 3469250 207
  • amy.brown@ontexglobal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 960 North Point Pkwy Suite100; Alpharetta, GA 30005 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3010692191
• FEI Number: 3010692191
• Name: Ontex BVBA
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• US Agent:
  • Amy L. Brown
  • Valor Brands LLC
  • 770 3469250 207
  • amy.brown@ontexglobal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5 Genthof ; Buggenhout Oost-Vlaanderen, B-9255 BE
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 3013684440
• FEI Number: 3013684440
• Name: Amy L. Brown
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• US Agent:
  • Amy L. Brown
  • Valor Brands LLC
  • 770 3469250 207
  • amy.brown@ontexglobal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 960 North Point Parkway, Suite 100 ; Alpharetta, GA 30005 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3012409274
• FEI Number: 3012409274
• Name: Amy L. Brown
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• US Agent:
  • Amy L. Brown
  • Valor Brands LLC
  • 770 3469250 207
  • amy.brown@ontexglobal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 960 North Point Parkway, Suite 100 ; Alpharetta, GA 30005 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3003449471
• FEI Number: 3003449471
• Name: Ontex Eeklo
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• US Agent:
  • Amy L. Brown
  • Valor Brands LLC
  • 770 3469250 207
  • amy.brown@ontexglobal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Korte Moeie 53 ; Eeklo Oost-Vlaanderen, 9900 BE
• Establishment Type: Manufacture Medical Device

• Registration Number: 3009046867
• FEI Number: 3009046867
• Name: GRUPO P.I. MABE SA DE CV
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• US Agent:
  • Amy L. Brown
  • Valor Brands LLC
  • 770 3469250 207
  • amy.brown@ontexglobal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Av. San Pablo Xochimehuacan 7213 Colonia La Loma ; Puebla Puebla, 72230 MX
• Establishment Type: Manufacture Medical Device

• Registration Number: 3003976701
• FEI Number: 3003976701
• Name: VALOR BRANDS LLC
• Owner & Operator: Ontex BVBA
• Contact Address: Korte Keppestraat 21 ; Aalst BE-VOV Oost-Vlaanderen 9320 BE
• Official Correspondent:
  • Bart Waterschoot
  • 32-53-333649-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 960 North Point Parkway, Suite 100 ; Alpharetta, GA 30005 US

FDA Filings

Device Company	Device	Date
PMN K191666 ONTEX BVBA	Unscented W Long Plastic And Cardboard Applicator Tampons	2019-12-20
PMN K162746 ONTEX BVBA	Ontex And Other Proprietary Names	2017-03-03
PMN K142786 ONTEX BVBA	Ontex Unscented Tampons With Colored Plastic Applicators	2015-06-23
PMN K132595 ONTEX BVBA	ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS	2014-04-23
PMN K132208 ONTEX BVBA	ONTEX AND OTHERS PROPRIETARY NAMES	2014-04-10
PMN K122603 ONTEX BVBA	ONTEX AND OTHER PROPRIETARY NAMES	2012-12-19

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092954515	Anvers,Belgium -> Savannah, Georgia	BLOSSOM TAMPS (HYGIENIC DISPOSABLES)	2380 BOX
2020092840331	Stadersand,Federal Republic of Germany -> Houston, Texas	BLOSSOM TAMPS (HYGIENIC DISPOSABLES)	10397 BOX
2020092840331	Stadersand,Federal Republic of Germany -> Houston, Texas	BLOSSOM TAMPS (HYGIENIC DISPOSABLES)	10397 BOX
2020092641424	Stadersand,Federal Republic of Germany -> Houston, Texas	BLOSSOM TAMPS	209 PKG
2020092657032	Anvers,Belgium -> Savannah, Georgia	BLOSSOM TAMPS (HYGIENIC DISPOSABLES)	2380 BOX
2020092641492	Anvers,Belgium -> Savannah, Georgia	BLOSSOM TAMPS	5200 PKG
2020092550648	Anvers,Belgium -> Norfolk, Virginia	FREIGHT PREPAID ADULT DIAPERS NET WEIGHT 9710.974 KG HS CODE 96190089 96190089 (HS) PORT CHARGES DESTINATION ARE PREPAID NOTIFY PARTY:	950 PCS
2020092546070	Anvers,Belgium -> Savannah, Georgia	BLOSSOM TAMPS (HYGIENIC DISPOSABLES)	2380 BOX
2020092362331	Anvers,Belgium -> Savannah, Georgia	BLOSSOM TAMPS (HYGIENIC DISPOSABLES)	2380 BOX