Menicon America Inc

FDA Filings

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

Menicon America Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3003515967
FEI Number3003515967
NameMENICON AMERICA, INC.
Owner & OperatorMENICON CO. LTD.
Contact Address21-19 AOI, 3-CHOME, NAKA-KU --
NAGOYA JP-23 Aiti 460-0006 JP
Official Correspondent
  • Tetsuji Kawai
  • 81-52-9351676-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address76 Treble Cove Rd., Bldg. #3
North Billerica, MA 01862 US
Establishment Type
  • Repack or Relabel Medical Device
  • Remanufacture Medical Device



FDA Filings

Device
Company
DeviceDate
MENICON AMERICA, INC.
LacriPure 2020-01-20
MENICON AMERICA, INC.
LacriPure 2020-01-20
MENICON AMERICA, INC.
Menicon Unique pH Multi-Purpose Solution 2020-01-20
MENICON AMERICA, INC.
Menicon Unique pH Multi-Purpose Solution 2020-01-20
MENICON AMERICA, INC.
Menicon Progent Protein Remover 2020-01-20
MENICON AMERICA, INC.
Menicon Progent Protein Remover 2020-01-20
MENICON AMERICA, INC.
Menicon Unique pH Multi-Purpose Solution 2020-01-20
MENICON AMERICA, INC. [MENICON CO. LTD.]
Miru 1month Menicon (1Month SiHy)2018-02-23
MENICON AMERICA, INC. [MENICON CO. LTD.]
Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens2016-02-08
MENICON AMERICA, INC. [MENICON CO. LTD.]
LacriPure2016-01-15
MENICON AMERICA, INC. [MENICON CO. LTD.]
MENICON PROGENT PROTEIN REMOVER2013-11-26
MENICON AMERICA, INC. [MENICON CO. LTD.]
Menicon Unique pH Multi-Purpose Solution2013-07-07
MENICON AMERICA, INC. [MENICON CO. LTD.]
Menicon Z Large Diameter2011-08-30
MENICON AMERICA, INC. [MENICON CO. LTD.]
Menicon Z Irregular Cornea2008-10-31
MENICON AMERICA, INC. [MENICON CO. LTD.]
Menicon Z DW2007-11-29
MENICON AMERICA, INC. [MENICON CO. LTD.]
MENICON Z RIGID GAS PERMEABLE CONTACT LENS2007-11-09
MENICON AMERICA, INC. [MENICON CO. LTD.]
MENICON Z RIGID GAS PERMEABLE CONTACT LENS2007-11-09

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202007294744Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyBARREL CASE10 CTN
2020070450891Anvers,Belgium -> Boston, MassachusettsEYE CARE PRODUCTS UNIQUE PH 75ML STARTER KIT & UNIQUE PH 120ML HS CODE : 33079000 ON 22 PA LLETS FREIGHT PAYABLE AT LE HAVRE1051 PKG
2020070356042Anvers,Belgium -> Boston, MassachusettsEYE CARE PRODUCTS UNIQUE PH 75ML STARTER KIT & UNIQUE PH 120ML HS CODE : 33079000 ON 22 PA LLETS FREIGHT PAYABLE AT LE HAVRE1051 PKG
2020062467817Anvers,Belgium -> Boston, MassachusettsOPHTHALMIC SOLUTION - UNIQUE PH 120 ML 330790 00FREIGHT PAYABLE AT LE HAVRE1124 PKG
2020060455890Anvers,Belgium -> Boston, MassachusettsEYE CARE PRODUCTS UNIQUE PH 75 ML STARTER KI T HS CODE 33079000 FREIGHT PAYABLE AT LE HAVR E576 PKG
2020032743680Anvers,Belgium -> Boston, MassachusettsOPHTHALMIC SOLUTION - UNIQUE PH 120 ML+ UNIQU E PH 75 ML FREIGHT PAYABLE AT LE HAVRE2383 PKG
2020032743680Anvers,Belgium -> Boston, MassachusettsOPHTHALMIC SOLUTION - UNIQUE PH 120 ML+ UNIQU E PH 75 ML2383 PKG
2020032743680Anvers,Belgium -> Boston, MassachusettsOPHTHALMIC SOLUTION - UNIQUE PH 120 ML+ UNIQU E PH 75 ML2383 PKG
2019121334268Anvers,Belgium -> Boston, MassachusettsUNIQUE PH 120 ML - OPHTALMIC SOLUTIONS HS COD E 33079000 LOT MP19292 + MP19293 20 PALLETS N ET WEIGHT : 3995 KGS FREIGHT PAYABLE AT LE HA VRE1041 PKG
2019071168777Anvers,Belgium -> Boston, MassachusettsOPHTHALMIC SOLUTION - UNIQUE PH 120 ML ON 20 PALLETS HS CODE : 33079000 TARE CONTENEUR : 3 940.00 KGS2401 PKG
2019071168777Anvers,Belgium -> Boston, MassachusettsOPHTHALMIC SOLUTION - UNIQUE PH 120 ML ON 23 PALLETS HS CODE : 33079000 TARE CONTENEUR : 3 700.00 KGS2401 PKG
2019071168777Anvers,Belgium -> Boston, MassachusettsOPHTHALMIC SOLUTION - UNIQUE PH 120 ML ON 11 PALLETS HS CODE : 33079000 TARE CONTENEUR : 2 200.00 KGS2401 PKG

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