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NIKKISO CO., LTD.

Japan·JP-MF-000019276

Last updated September 17, 2026

Information

Country
Japan
Address
20-3 EBISU 4-CHOME,, SHIBUYA-KU Tokyo
Website
nikkiso.co.jp
LinkedIn
—
Facebook
—
Phone
+81334433727
PRRC Contact
SATOKO HINA
EUDAMED SRN
JP-MF-000019276
FDA FEI Number
3014638255
DUNS Number
690542378

Catalogue (23)

DeviceModel / ReferenceRegistriesClassStatus
Hemodialysis Delivery System DBB-06
FDA UDI
Class IIActive
Hemodialysis Delivery System DBB-06
FDA UDI
Class IIActive
Filter for dialysate purification EF-02D
FDA UDI
Class IIActive
Blood Tubing Lines for Hemodialysis C18SFD-E(U)
FDA UDI
Class IIActive
Blood Tubing Lines For Hemodialysis AV06C-P
FDA UDI
Class IIActive
Blood Tubing Lines for Hemodialysis AL-CDC-E(U)
FDA UDI
Class IIActive
Hemodialysis Delivery System DBB-06 PRO
FDA UDI
Class IIActive
Blood Tubing Lines for Hemodialysis AV06C-E
FDA UDI
Class IIActive
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series K230514
FDA 510(k)
Class IIActive
Dbb-06 Hemodialysis Delivery System K091978
FDA 510(k)
Class IIActive
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU K242479
FDA 510(k)
Class IIActive
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) K242176
FDA 510(k)
Class IIActive
DBB-06 Hemodialysis Delivery System K152938
FDA 510(k)
Class IIActive
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) K242155
FDA 510(k)
Class IIActive
Modification To Dbb-05 Hemodialysis Delivery System K061519
FDA 510(k)
Class IIActive
Nikkiso Nd-14 Parallel Flow Dialyzer K803068
FDA 510(k)
Class IIActive
Nikkline Blood Tubing Lines With Transducer Protectors, Models Av06a-P, Avo6b-P, Av06c-P K082719
FDA 510(k)
Class IIActive
Blood Tubing Lines for Hemodialysis AV06C-E K231589
FDA 510(k)
Class IIActive
Nikkiso Co, Ltd., Flx10gw, 12gw, 15gw, 18gw & 21gw Hemodialyzers K953996
FDA 510(k)
Class IIActive
Haemodialysis Equipment DO-F371-00
EUDAMED
Class IIbActive
Blood Tubing Lines for Hemodialysis DO-F418-00
EUDAMED
Class IIaActive
Haemodialysis Equipment 3313
EUDAMED
Class IIbActive
Blood Tubing Lines for Hemodialysis DO-F418-00
EUDAMED
Class IIaActive

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