Regulations research / FDA data / Establishments and listings / NIPRO BioHole Needle with CAPICK, Scab Remover Establishments and listings NIPRO BioHole Needle with CAPICK, Scab Remover NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 FIE
K number K100520
Proprietary name NIPRO BioHole Needle with CAPICK, Scab Remover
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code FIE
Created date 2010-04-13
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Needle, Fistula
Medical specialty description Gastroenterology, Urology
Regulation number 876.5540
Device class 2
K number K100520 Establishments and listings ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M. NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 KDI
K number K131935
Proprietary name ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M.
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code KDI
Created date 2014-01-30
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical specialty description Gastroenterology, Urology
Regulation number 876.5860
Device class 2 Establishments and listings Nipro NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 KPO
K number K131202
Proprietary name Nipro
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code KPO
Created date 2026-02-02
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Medical specialty description Gastroenterology, Urology
Regulation number 876.5820
Device class 2 Establishments and listings NIPRO Transducer Protector TP-SURE NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 FIB
K number K072988
Proprietary name NIPRO Transducer Protector TP-SURE
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code FIB
Created date 2008-03-31
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Protector, Transducer, Dialysis
Medical specialty description Gastroenterology, Urology
Regulation number 876.5820
Device class 2
K number K072988 Establishments and listings Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 FJK
K number K112628
Proprietary name Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code FJK
Created date 2012-11-22
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Medical specialty description Gastroenterology, Urology
Regulation number 876.5820
Device class 2
K number K112628 Establishments and listings Nipro SafeTouch Safety BCS NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 FMI FOZ
K number K011297
Proprietary name Nipro SafeTouch Safety BCS
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code FMI
Created date 2007-11-15
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Needle, Hypodermic, Single Lumen
Medical specialty description General Hospital
Regulation number 880.5570
Device class 2
Product code FOZ
Created date 2007-11-15
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Medical specialty description General Hospital
Regulation number 880.5200
Device class 2 Establishments and listings Nipro Syringe NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 FMI FMF
K number K191359
Proprietary name Nipro Syringe
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code FMI
Created date 2021-03-10
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Needle, Hypodermic, Single Lumen
Medical specialty description General Hospital
Regulation number 880.5570
Device class 2
Product code FMF
Created date 2021-03-10
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Syringe, Piston
Medical specialty description General Hospital
Regulation number 880.5860
Device class 2 Establishments and listings Set, Administration, Intravascular NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 FPA
K number K113471
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code FPA
Created date 2012-11-20
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Set, Administration, Intravascular
Medical specialty description General Hospital
Regulation number 880.5440
Device class 2
K number K113471 Establishments and listings Nipro SafeTouch II Safety AVF NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 FOZ
K number K032777
Proprietary name Nipro SafeTouch II Safety AVF
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code FOZ
Created date 2007-11-15
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Medical specialty description General Hospital
Regulation number 880.5200
Device class 2 Establishments and listings Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle NIPRO MEDICAL CORPORATION · Miramar, US
Complaint File Establishment per 21 CFR 820.198 Reg. 1056186 FMF FMI
K number K222852
Proprietary name Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
Establishment type Complaint File Establishment per 21 CFR 820.198 Registration
Registration number 1056186
FEI number 1000132332
Status code 1
Initial importer flag Y
Reg expiry date year 2027
Name NIPRO MEDICAL CORPORATION
Address line 1 3100 Sw 145th Ave Ste 100
City Miramar
State code FL
Iso country code US
Zip code 33027 Owner operator
Firm name NIPRO CORPORATION
Owner operator number 8030375 Contact address
Address 1 3-26, Senriokashinmachi
City Settsu
State code JP-27
State province Osaka
Iso country code JP
Postal code 566-8510 Products
Product code FMF
Created date 2023-12-01
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Syringe, Piston
Medical specialty description General Hospital
Regulation number 880.5860
Device class 2
Product code FMI
Created date 2023-12-01
Owner operator number 8030375 Harmonized identifiers (openFDA)
Device name Needle, Hypodermic, Single Lumen
Medical specialty description General Hospital
Regulation number 880.5570
Device class 2 28 records share this identifier (an establishment lists each device separately); the first 10 are shown.
Wholesale access for licensed clinicians. Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.
Data from openFDA , FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.
