Apex Medical Corp

FDA Filings

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

TAIWANTAIWAN STOCK EXCHANGE4106DUNS 656413127
FDA Registration(s)
Registration Number3006339858
FEI Number3006339858
NameFang Yu Chu
Owner & OperatorAPEX MEDICAL CORP.
Contact AddressNo. 9, MIN SHENG ST., TU-CHENG,
NEW TAIPEI CITY TW-TPQ Taipei - District 23679 TW
Official Correspondent
  • Chieh - Yang
  • 886-2-22685568-5102
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address927 Mariner Street,
Brea, CA 92821 US
Establishment TypeManufacture Medical Device



Registration Number2087444
FEI Number3003560244
NameApex Medical USA Corp.
Owner & OperatorAPEX MEDICAL CORP.
Contact AddressNo. 9, MIN SHENG ST., TU-CHENG,
NEW TAIPEI CITY TW-TPQ Taipei - District 23679 TW
Official Correspondent
  • Chieh - Yang
  • 886-2-22685568-5102
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address927 Mariner Street
Brea, CA 92821 US



Registration Number8043439
FEI Number3004411059
NameAPEX MEDICAL CORP.
Owner & OperatorAPEX MEDICAL CORP.
Contact AddressNo. 9, MIN SHENG ST., TU-CHENG,
NEW TAIPEI CITY TW-TPQ Taipei - District 23679 TW
Official Correspondent
  • Chieh - Yang
  • 886-2-22685568-5102
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNo. 9, MIN SHENG ST., TU-CHENG
NEW TAIPEI CITY Taipei - District, 23679 TW
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Apex Medical Corp.
WiZARD 510 Nasal Mask2020-10-29
APEX MEDICAL CORP.
APEX 2019-07-09
APEX MEDICAL CORP.
APEX 2019-07-09
APEX MEDICAL CORP.
APEX 2019-07-09
APEX MEDICAL CORP.
APEX 2019-07-09
APEX MEDICAL CORP.
APEX 2019-07-09
APEX MEDICAL CORP.
APEX 2019-07-09
APEX MEDICAL CORP.
WiZARD 320 Full Face Mask2019-06-04
APEX MEDICAL CORP.
WiZARD 310 Nasal Mask2019-06-04
Apex Medical Corp.
WiZARD 310/320 Series CPAP Mask2019-05-17
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
APEX 2018-08-06
APEX MEDICAL CORP.
BED, AC-POWERED ADJUSTABLE HOSPITAL2018-08-01
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
APEX 2018-07-06
APEX MEDICAL CORP.
Stryker 2018-06-25
APEX MEDICAL CORP.
APEX 2018-04-27
APEX MEDICAL CORP.
APEX 2018-04-27
APEX MEDICAL CORP.
APEX 2018-04-27
APEX MEDICAL CORP.
APEX 2018-04-27
APEX MEDICAL CORP.
APEX 2018-04-27
APEX MEDICAL CORP.
APEX 2018-03-29
APEX MEDICAL CORP.
APEX 2018-03-29
APEX MEDICAL CORP.
APEX 2018-03-29
APEX MEDICAL CORP.
APEX 2018-03-29
APEX MEDICAL CORP.
Tubing2016-08-08
APEX MEDICAL CORP.
CPAP Tubing2016-08-08
APEX MEDICAL CORP.
Apex Medical Corp. ICH CPAP With PVA 9S-007XXX Series2015-09-15
APEX MEDICAL CORP.
iCH Sense (9S-007001)2015-09-15
APEX MEDICAL CORP.
iCH Prime (9S-007101)2015-09-15
APEX MEDICAL CORP.
iCH Auto (9S-007201)2015-09-15
APEX MEDICAL CORP.
iCH Sense2015-03-20
APEX MEDICAL CORP.
iCH Prime2015-03-20
APEX MEDICAL CORP.
iCH Auto2015-03-20
APEX MEDICAL CORP.
APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES2014-10-06
APEX MEDICAL CORP.
XT Sense (9S-005530)2013-08-19
APEX MEDICAL CORP.
XT Prime (9S-005580)2013-08-19
APEX MEDICAL CORP.
XT Fit (9S-005500)2013-08-19
APEX MEDICAL CORP.
XT Auto (9S-005720)2013-08-19
APEX MEDICAL CORP.
WiZARD 230 Nasal Pillows Mask Series2013-06-13
APEX MEDICAL CORP.
SM03002, Ms. WiZARD 230 Nasal Pillows Mask with Headgear2013-06-13
APEX MEDICAL CORP.
SM03001, Mr. WiZARD 230 Nasal Pillows Mask with Headgear2013-06-13
APEX MEDICAL CORP.
SM00024, Headgear Set, Light Blue2013-06-13
APEX MEDICAL CORP.
SM00023, Headgear Set, Lavender2013-06-13
APEX MEDICAL CORP.
SM00022, Elbow Connector with Short Tube2013-06-13
APEX MEDICAL CORP.
SM00021, Mask Frame2013-06-13
APEX MEDICAL CORP.
SM00020, XS Nasal Pillows Cushion2013-06-13
APEX MEDICAL CORP.
SM00019, S Nasal Pillows Cushion2013-06-13
APEX MEDICAL CORP.
SM00018, M Nasal Pillows Cushion2013-06-13
APEX MEDICAL CORP.
SM00017, L Nasal Pillows Cushion2013-06-13
APEX MEDICAL CORP.
WIZARD 230 NASAL PILOW MASK2013-06-06
APEX MEDICAL CORP.
APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-0057202012-12-06
APEX MEDICAL CORP.
iCH CPAP 9S-007XXX Series2012-05-31
APEX MEDICAL CORP.
iCH Auto (9S-007201), iCH Prime (9S-007101), iCH Sense (9S-007001)2012-05-31
APEX MEDICAL CORP.
Vac Pro2012-05-31
APEX MEDICAL CORP.
Vac Plus2012-05-31
APEX MEDICAL CORP.
Vac Maxi2012-05-31
APEX MEDICAL CORP.
APEX MEDICAL ICH CPAP SERIES (9S-007XXX)2012-05-16
APEX MEDICAL CORP.
WiZARD 220 Full Face Mask (SW) (SM02018)2011-11-14
APEX MEDICAL CORP.
WiZARD 220 Full Face Mask (S) (SM02012)2011-11-14
APEX MEDICAL CORP.
WiZARD 220 Full Face Mask (MW) (SM02017)2011-11-14
APEX MEDICAL CORP.
WiZARD 220 Full Face Mask (M) (SM02011)2011-11-14
APEX MEDICAL CORP.
WiZARD 220 Full Face Mask (LW) (SM02016)2011-11-14
APEX MEDICAL CORP.
WiZARD 220 Full Face Mask (L) (SM02010)2011-11-14
APEX MEDICAL CORP.
WiZARD 210 Nasal Mask (XS) (SM01011)2011-11-14
APEX MEDICAL CORP.
WiZARD 210 Nasal Mask (S) (SM01010)2011-11-14
APEX MEDICAL CORP.
WiZARD 210 Nasal Mask (M) (SM01009)2011-11-14
APEX MEDICAL CORP.
WiZARD 210 Nasal Mask (L) (SM01008)2011-11-14
APEX MEDICAL CORP.
SM00036, WiZARD 220 Elbow Connector with Port Cap (S/SW/MW)2011-11-14
APEX MEDICAL CORP.
SM00035, WiZARD 220 Elbow Connector with Port Cap (M/L/LW)2011-11-14
APEX MEDICAL CORP.
SM00034, WiZARD 210 Elbow Connector with Port Cap2011-11-14
APEX MEDICAL CORP.
SM00030, WiZARD 210 Nasal Mask Cushin, XS2011-11-14
APEX MEDICAL CORP.
SM00028, WiZARD 210/220 Forehead Pad, Extra High2011-11-14
APEX MEDICAL CORP.
SM00027, WiZARD 220 Full Face Mask Cushion, SW2011-11-14
APEX MEDICAL CORP.
SM00026, WiZARD 220 Full Face Mask Cushion, MW2011-11-14
APEX MEDICAL CORP.
SM00025, WiZARD 220 Full Face Mask Cushion, LW2011-11-14
APEX MEDICAL CORP.
SM00016, Small Silicon Tubing2011-11-14
APEX MEDICAL CORP.
SM00012, WiZARD 210/220 Forehead Pad, High2011-11-14
APEX MEDICAL CORP.
SM00011, WiZARD 210/220 Forehead Pad, Standard2011-11-14
APEX MEDICAL CORP.
SM00010, WiZARD 210/220 Buckles2011-11-14
APEX MEDICAL CORP.
SM00009, WiZARD 210/220 Headgear with Buckles2011-11-14
APEX MEDICAL CORP.
SM00006, WiZARD 220 Full Face Mask Cushion, S2011-11-14
APEX MEDICAL CORP.
SM00005, WiZARD 220 Full Face Mask Cushion, M2011-11-14
APEX MEDICAL CORP.
SM00004, WiZARD 220 Full Face Mask Cushion, L2011-11-14
APEX MEDICAL CORP.
SM00003, WiZARD 210 Nasal Mask Cushin, S2011-11-14
APEX MEDICAL CORP.
SM00002, WiZARD 210 Nasal Mask Cushin, M2011-11-14
APEX MEDICAL CORP.
SM00001, WiZARD 210 Nasal Mask Cushin, L2011-11-14
APEX MEDICAL CORP.
APEX Medical Wizard Series CPAP Mask2011-11-14
APEX MEDICAL CORP.
Shower Bench2011-06-08
APEX MEDICAL CORP.
APEX MEDICAL WIZARD SERIES CPAP MASK2011-05-06
APEX MEDICAL CORP.
VACPLUS SUCTION UNIT2011-02-24
APEX MEDICAL CORP.
XT Auto CPAP 9S-005XXX2009-12-17
APEX MEDICAL CORP.
APEX MEDICAL XT AUTO CPAP 9S-0052002009-04-22
APEX MEDICAL CORP.
FOLDING REACHER2008-08-04
APEX MEDICAL CORP.
Mobineb, 9R-027 series2007-12-25
APEX MEDICAL CORP.
XTn CPAP Series2007-12-25
APEX MEDICAL CORP.
XTI, XTIII, XT III Plus2007-12-25
APEX MEDICAL CORP.
XT Sense (9S-005531), XT Fit (9S-005501)2007-12-25
APEX MEDICAL CORP.
PureSom2007-12-25
APEX MEDICAL CORP.
XT Water Chamber2007-12-25
APEX MEDICAL CORP.
XT Heated Humidifier2007-12-25
APEX MEDICAL CORP.
XT Heated Humidifier (9S-006501)2007-12-25
APEX MEDICAL CORP.
XT Heated Humidifier (9S-006500)2007-12-25
APEX MEDICAL CORP.
9S-003, 9S-004000, 9S-006000, 9S-0065002007-12-25
APEX MEDICAL CORP.
APEX MEDICAL MOBINEB, 9R-027 SERIES2007-05-18
APEX MEDICAL CORP.
APEX MEDICAL XT1 CPAP, MODEL 9S-0052007-05-04
APEX MEDICAL CORP.
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-0042006-12-06
APEX MEDICAL CORP.
NASAL MASK2006-01-18
APEX MEDICAL CORP.
FULL FACE MASK2006-01-18
APEX MEDICAL CORP.
APEX MEDICAL MININEB & MINIPLUS2005-02-16
APEX MEDICAL CORP.
APEX MEDICAL DIGITAL TENS TS1211, TS12122002-06-12
APEX MEDICAL CORP.
WOODEN TRANSFER BOARD2002-04-01
APEX MEDICAL CORP.
WALL GRAB BAR2002-04-01
APEX MEDICAL CORP.
PLASTIC TRANSFER BOARD2002-04-01
APEX MEDICAL CORP.
Hair Wash Tray2002-04-01
APEX MEDICAL CORP.
MODIFICATION TO:APEX MEDICAL IF-41002001-12-14
APEX MEDICAL CORP.
APEX MEDICAL LCD TENS-VII2001-10-29
APEX MEDICAL CORP.
AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-1406002001-08-24
APEX MEDICAL CORP.
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T2001-07-27
APEX MEDICAL CORP.
OVERDOOR TRACTION SET2000-10-23
APEX MEDICAL CORP.
EXERCISE PULLEY SET2000-10-23
APEX MEDICAL CORP.
APPARATUS, TRACTION, NON-POWERED2000-10-23
APEX MEDICAL CORP.
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-1001002000-06-05
APEX MEDICAL CORP.
ACU-STIM TENS, AP-101082T1998-07-29
APEX MEDICAL CORP.
MULTI-STIM TENS, AP-101081T1998-07-29
APEX MEDICAL CORP.
MICRO II MICROCURRENT TENS1998-07-29
Fang Yu Chu [APEX MEDICAL CORP.]
Flexi-Air Hybrid Mattress1998-01-08
APEX MEDICAL CORP.
Cover, Mattress (Medical Purpose)1998-01-08
APEX MEDICAL CORP.
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T1997-04-29
APEX MEDICAL CORP.
Accessories, Wheelchair1997-02-07
APEX MEDICAL CORP.
Table, Mechanical1997-02-07
APEX MEDICAL CORP.
MINI CARE1996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
eco Star1996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
eco Neb1996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
Penguin Neb1996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
Minicare1996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
Mini Star1996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
Mini Plus1996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
Mini Neb1996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
BestNeb, AP-1001001996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
9R-029xxx (835x-1)1996-07-17
APEX MEDICAL CORP.
eco Star1996-07-17
APEX MEDICAL CORP.
eco Neb1996-07-17
APEX MEDICAL CORP.
Penguin Neb1996-07-17
APEX MEDICAL CORP.
Minicare1996-07-17
APEX MEDICAL CORP.
Mini Star1996-07-17
APEX MEDICAL CORP.
Mini Plus1996-07-17
APEX MEDICAL CORP.
Mini Neb1996-07-17
APEX MEDICAL CORP.
BestNeb, AP-1001001996-07-17
APEX MEDICAL CORP.
9R-029xxx (835x-1)1996-07-17
Fang Yu Chu [APEX MEDICAL CORP.]
Sedens 400, Sedens 5001994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
SUPRA Series Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
SERENE Series Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
Pro-care Turn & Pro-care Optima Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
PRO-CARE Series Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
PM Series Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
NEO Series Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
Flexi-Air1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
Excel Series Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
Dyna Series Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
DOMUS Series Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
COMBO 100 PLUS Series Pump and Seat Cushion, COMBO Series Pump and Mattress1994-09-21
Fang Yu Chu [APEX MEDICAL CORP.]
ACS Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
Sedens 400, Sedens 5001994-09-21
APEX MEDICAL CORP.
SUPRA Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
SERENE Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
Pro-care Turn & Pro-care Optima Pump and Mattress1994-09-21
APEX MEDICAL CORP.
PRO-CARE Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
PM Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
NEO Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
Flexi-Air1994-09-21
APEX MEDICAL CORP.
Excel Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
Dyna Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
DOMUS Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
COMBO 100 PLUS Series Pump and Seat Cushion, COMBO Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
ACS Series Pump and Mattress1994-09-21
APEX MEDICAL CORP.
Walker, Mechanical1993-11-30
APEX MEDICAL CORP.
CANE1993-11-30

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092654544Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL EQUIPMENT50 CTN
2020092346441Shanghai ,China (Mainland) -> Long Beach, CaliforniaMEDICAL EQUIPMENT12 CTN
2020092254701Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL EQUIPMENT (STURDY AUTOCLAVE SUPER MIC ROM) 3CTNS(2PLYWOOD PALLETS) P/O NO.P10214 H.S. CODE: 8419.20 AMS#PSLAP20089251LAX3 CTN
2020091548196Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL EQUIPMENT (CONTINUOUS POSITIVE AIRWAY PRESSURE & PARTS) H.S. CODE: 9019.20 PUMP AN D MATTRESS H.S. CODE: 9019.10 PLASTIC BAG/BO TTLE/ L TYPE FOLDER H.S. CODE: 3923.29 NECK PILLOW H.S. CODE: 4016.10 P/O NO.P10211 LIS TING NO.D249099,510K NO.K150111 LISTING NO.D2 01137,510K NO.K112079 LISTING NO.D030064,510K43 CTN
202009048406Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT PUMP15 CTN
2020083113738Shanghai ,China (Mainland) -> Charleston, South CarolinaMEDICAL PUMP527 CTN
2020082234513Shanghai ,China (Mainland) -> Long Beach, CaliforniaMEDICAL EQUIPMENT(NEBULIZER)1365 CTN
2020081566503Taipei,China (Taiwan) -> Los Angeles, CaliforniaMEDICAL EQUIPMENT (CONTINUOUS POSITIVE AIRWAY PRESSURE & PARTS) LISTING NO.D030063,510K NO .K070609 LISTING NO.D350646,510K NO.K182394 F DA OWNER ID & ESTAB. NO.: 9001426, 8043439 (A PEX) P/O NO.P10210 H.S. CODE:9019.20 47PKGS {[46CTNS+1BUNDLE]3PLTS} AMS#PSLAP20079115LAX47 PKG

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