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Kaneka Medical America LLC

Matched from indexed company URL: KANEKA CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24351512435151Kaneka Medical America LLC1Y2026-01-01623 Fifth Avenue New York NY US 10022
30097615733009761573KANEKA MEDIX CORPORATION KANAGAWA PLANT1N2026-01-01225-1 Aza Deguchi, Yamakita Yamakita-machi Ashigara-Kami-gun Kanagawa JP 2580113
30147587553014758755KANEKA AMERICAS HOLDING INC1N2026-01-017979 Gateway Blvd Newark CA US 94560
30314087343031408734KANEKA CORPORATION TOMATOH PLANT1N2026-01-016-253, Aza Kashiwabara Tomakomai-city Hokkaid? JP 059-1362

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04540778177086i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx
04540778177116i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx
04540778193710i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx
04540778193727i-ED COIL - The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.(800) 526-3522xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3375941256941659P910018LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).MMY1996-02-21
3475381430585149K251668SurfRider 13 MicrocatheterQJP2026-01-05
1446121888905219K210638i-ED COIL SystemHCG2021-03-26
1446121996704147K170247Lacriflow CLOKS2017-04-18
1446121710466092K121301XPRESSWAY RX CATHETER (6F LD-VERISON)QEZ2012-07-30
1446121890717006K120886LACRIFASTOKS2012-12-17
1446121118856797K101839KANEKA PHARMA AMERICA XPRESS-WAY RXQEZ2010-10-22
3375941110650477H170002
3375941040226610H120005

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OKS22017-04-18
QEZ22012-07-30
QJP12026-01-05
HCG12021-03-26
MMY11996-02-21

PMA#

PMN#

GUDID#

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