FDA Registration
Active
🇯🇵 Japan
KAI INDUSTRIES CO., LTD.
Reg #: 8031525
·
FEI: 6827
·
Expires 2026
Products
9
Proprietary Names
191
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- KAI INDUSTRIES CO., LTD.
- Registration Number
- 8031525
- FEI Number
- 6827
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1110 OYANA
- City
- SEKI CITY Gifu
- Country
- JP
Owner / Operator
- Firm Name
- KAI INDUSTRIES CO., LTD.
- Operator Number
- 8031525
- Address
- 1110 Oyana
- City
- Seki
- State
- Gifu
- Postal Code
- 5013992
- Country
- JP
US Agent
- Business Name
- KAI USA LTD.
- Contact Name
- Noritaka Sawamura
- Address
- 18600 S.W. TETON AVE.
- City
- TUALATIN
- State
- OR
- ZIP
- 97062
- Country
- US
- [email protected]
- Phone
- 503 6821966
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1992-12-07 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2003-10-07 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-11-04 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2001-11-08 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2001-11-08 |
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2017-12-05 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2007-12-20 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 1985-03-14 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2002-07-16 |
Proprietary Names
RNU-52AGF BEVEL UP, 45 DEGREE BENT WIDTH 5.2MM ANTI-GLARE TYPE
VK-19GF MVR 19 GAUGE VITRECTOMY KNIFE dia. 1MM
SP-S15 ANGLE 15 DEGREE WIDTH 1MM THICKNESS 0.1MM
BKB-10AGF BEVEL UP, 45 DEGREE BENT WIDTH 1MM ANTI-GLARE TYPE
ST30 ANGLE 30 DEGREE THICKNESS 0.12MM
SK-SLU20 MBEVEL UP, 45 DEGREE BENT WIDTH 2MM
CCR-28AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.8MM ANTI-GLARE TYPE
CCR-30AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3MM ANTI-GLARE TYPE
A-15F ANGLE 15 DEGREE THICKNESS 0.1MM
SK-CPU26 BEVEL UP, 45 DEGREE BENT WIDTH 2.6MM ANTI-GLARE TYPE
CCR-32AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3.2MM ANTI-GLARE TYPE
A-30F ANGLE 30 DEGREE THICKNESS 0.1MM
SLU-25AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.5MM ANTI-GLARE TYPE
SK-CCR20 MDOUBLE BEVEL, 45 DEGREE BENT WIDTH 2MM
CCR-24AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.4MM ANTI-GLARE TYPE
RNU-56AGF BEVEL UP, 45 DEGREE BENT WIDTH 5.6MM ANTI-GLARE TYPE
SK-CCR30 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3MM
SLU-285AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.85MM ANTI-GLARE TYPE
SK-CPU16 BEVEL UP, 45 DEGREE BENT WIDTH 1.6MM ANTI-GLARE TYPE
TR-15/19AGF BEVEL UP, 45 DEGREE BENT 1.5x1.9 ANTI-GLARE TYPE
CCR-20AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2MM ANTI-GLARE TYPE
CCR-23AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.3MM ANTI-GLARE TYPE
SLU-30AGF BEVEL UP, 45 DEGREE BENT WIDTH 3MM ANTI-GLARE TYPE
SLU-265AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.65MM ANTI-GLARE TYPE
SK-A225 ANGLE 22.5 DEGREE THICKNESS 0.1MM
PCB-10AGF ANGLED 1MM WIDTH THICKNESS 0.1MM
SK-VKB20G MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM BENT TYPE
SK-CCR32 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3.2MM
SK-SLU22 BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM
A-45F ANGLE 45 DEGREE THICKNESS 0.1MM
ST15 ANGLE 15 DEGREE THICKNESS 0.12MM
CCR-25AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.5MM ANTI-GLARE TYPE
CC28 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.8MM
SK-SLU28 BEVEL UP, 45 DEGREE BENT WIDTH 2.8MM
SLU-13AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.3MM ANTI-GLARE TYPE
SL275 BEVEL UP, 45 DEGREE BENT WIDTH 2.75MM
SLU-15AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.5MM ANTI-GLARE TYPE
CC275 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.75MM
SLU-16AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.6MM ANTI-GLARE TYPE
SK-SLU18 MBEVEL UP, 45 DEGREE BENT WIDTH 1.8MM
SLU-24AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.4MM ANTI-GLARE TYPE
SLU-32AGF BEVEL UP, 45 DEGREE BENT WIDTH 3.2MM ANTI-GLARE TYPE
CPU-26AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.6MM ANTI-GLARE TYPE
SLU-19AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.9MM ANTI-GLARE TYPE
SLU-20AGF BEVEL UP, 45 DEGREE BENT WIDTH 2MM ANTI-GLARE TYPE
SL22 BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM
SP-U10 BEVEL UP, 45 DEGREE BENT WIDTH 1MM ANTI-GLARE TYPE
SLU-22AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE
VK-20GF MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM
RNU-51AGF BEVEL UP, 45 DEGREE BENT WIDTH 5.1MM ANTI-GLARE TYPE
CCR-265AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.65MM ANTI-GLARE TYPE
BKS-10AGF BEVEL UP, STRAIGHT WIDTH 1MM ANTI-GLARE TYPE
ST225 ANGLE 22.5 DEGREE THICKNESS 0.12MM
SK-CPU22 BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE
SL24 BEVEL UP, 45 DEGREE BENT WIDTH 2.4MM
CPU-16AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.6MM ANTI-GLARE TYPE
VKB-20GF MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM BENT TYPE
SK-A15 ANGLE 15 DEGREE THICKNESS 0.1MM
SK-SLU30 BEVEL UP, 45 DEGREE BENT WIDTH 3MM
SP-T12 BEVEL UP, 30 DEGREE BENT 0.5x1.2 ANTI-GLARE TYPE
VK25 MVR 25 GAUGE VITRECTOMY KNIFE dia. 0.5MM
SLU-14AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.4MM ANTI-GLARE TYPE
CC24 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.4MM
CCR-18AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 1.8MM ANTI-GLARE TYPE
SK-SLU23 BEVEL UP, 45 DEGREE BENT WIDTH 2.3MM
SK-CCR22 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.2MM
CC22 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.2MM
CCR-22AGF DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE
TR-125/14AGF BEVEL UP, 45 DEGREE BENT 1.25x1.4 ANTI-GLARE TYPE
SLU-275AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.75MM ANTI-GLARE TYPE
SK-A30 ANGLE 30 DEGREE THICKNESS 0.1MM
SK-CCR18 MDOUBLE BEVEL, 45 DEGREE BENT WIDTH 1.8MM
PCT-10F STRAIGHT 1MM WIDTH THICKNESS 0.1MM
CPU-22AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.2MM ANTI-GLARE TYPE
SK-CCR24 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.4MM
SL30 BEVEL UP, 45 DEGREE BENT WIDTH 3MM
A-0F ANGLE 0 DEGREE THICKNESS 0.1MM
VK23 MVR 23 GAUGE VITRECTOMY KNIFE dia. 0.6MM
CC30 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 3MM
SLU-23AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.3MM ANTI-GLARE TYPE
SLU-18AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.8MM ANTI-GLARE TYPE
TR-12/14AGF BEVEL UP, 45 DEGREE BENT 1.2x1.4 ANTI-GLARE TYPE
SLU-17AGF BEVEL UP, 45 DEGREE BENT WIDTH 1.7MM ANTI-GLARE TYPE
VK-23GF MVR 23 GAUGE VITRECTOMY KNIFE dia. 0.6MM
SK-SLU24 BEVEL UP, 45 DEGREE BENT WIDTH 2.4MM
A-225F ANGLE 22.5 DEGREE THICKNESS 0.1MM
SK-CCR28 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.8MM
VK20 MVR 20 GAUGE VITRECTOMY KNIFE dia. 0.9MM
RNU-41AGF BEVEL UP, 45 DEGREE BENT WIDTH 4.1MM ANTI-GLARE TYPE
SK-CCR23 DOUBLE BEVEL, 45 DEGREE BENT WIDTH 2.3MM
SLU-28AGF BEVEL UP, 45 DEGREE BENT WIDTH 2.8MM ANTI-GLARE TYPE
SL28 BEVEL UP, 45 DEGREE BENT WIDTH 2.8MM
CWU-26AGF BEVEL UP, 60 DEGREE BENT WIDTH 2.6MM ANTI-GLARE TYPE
SK-SLU32 BEVEL UP, 45 DEGREE BENT WIDTH 3.2MM
HANDLE, SCALPEL
PLASTIC KNIFE HANDLE STYLE NO.3
PLASTIC KNIFE HANDLE STYLE NO.4
CURETTE, SURGICAL, GENERAL USE
DERMAL CURETTE 4MM
DERMAL CURETTE 3MM
DERMAL CURETTE 2MM
DERMAL CURETTE 7MM
DERMAL CURETTE 5MM
Microtome Blade; HP35 Coated, HP35 Ultra, MB22 Premier, MB35 Premier, MX35 Premier, MX35 Premier+, MX35 Ultra
PUNCH, SURGICAL
BIOPSY PUNCH 4MM
BIOPSY PUNCH WITH PLUNGER 3MM
BIOPSY PUNCH 3MM
BIOPSY PUNCH WITH PLUNGER 1.5MM
BIOPSY PUNCH 3.5MM
BIOPSY PUNCH WITH PLUNGER 1MM
BIOPSY PUNCH 8MM
BIOPSY PUNCH 5MM
BIOPSY PUNCH 6MM
BIOPSY PUNCH WITH PLUNGER 4MM
BIOPSY PUNCH 1MM
BIOPSY PUNCH 2MM
BIOPSY PUNCH 2.5MM
BIOPSY PUNCH 1.5MM
BIOPSY PUNCH WITH PLUNGER 2MM
BLADE, SCALPEL
COATED SURGICAL BLADE NO.20 - STAINLESS
COATED SURGICAL BLADE NO.23 - STAINLESS
CARBON STEEL BLADE NO.25
CARBON STEEL BLADE NO.24
COATED SURGICAL BLADE NO.24 - STAINLESS
STAINLESS STEEL BLADE NO.11
COATED SURGICAL BLADE NO.12 - STAINLESS
COATED SURGICAL BLADE NO.15 - STAINLESS
STAINLESS STEEL BLADE NO.21
STAINLESS STEEL BLADE NO.12
CARBON STEEL BLADE NO.15C
STAINLESS STEEL BLADE NO.15
CARBON STEEL BLADE NO.23
CARBON STEEL BLADE NO.21
CARBON STEEL BLADE NO.12
STAINLESS STEEL BLADE NO.20
CARBON STEEL BLADE NO.15
COATED SURGICAL BLADE NO.25 - STAINLESS
STAINLESS STEEL BLADE NO.15C
CARBON STEEL BLADE NO.11
COATED SURGICAL BLADE NO.10 - STAINLESS
STAINLESS STEEL BLADE NO.23
CARBON STEEL BLADE NO.22
COATED SURGICAL BLADE NO.21 - STAINLESS
CARBON STEEL BLADE NO.20
CARBON STEEL BLADE NO.10
CARBON STEEL BLADE NO.12B
STAINLESS STEEL BLADE NO.24
STAINLESS STEEL BLADE NO.10
COATED SURGICAL BLADE NO.22 - STAINLESS
COATED SURGICAL BLADE NO.11 - STAINLESS
STAINLESS STEEL BLADE NO.22
STAINLESS STEEL BLADE NO.25
STAINLESS STEEL BLADE NO.12B
COATED SURGICAL BLADE NO.14 - STAINLESS
BIOPSIBLADE
SCALPEL, ONE-PIECE
KAI Disposable Mini-Scalepl
COATED DISPOSABLE SCALPEL NO.22
DISPOSABLE SCALPEL NO.12
COATED DISPOSABLE SCALPEL NO.10
DISPOSABLE SAFETY SCALPEL NO.24
COATED DISPOSABLE SCALPEL NO.14
DISPOSABLE SCALPEL NO.10
DISPOSABLE SAFETY SCALPEL NO.11
DISPOSABLE SAFETY SCALPEL NO.12
DISPOSABLE SAFETY SCALPEL NO.21
DISPOSABLE SAFETY SCALPEL NO.22
COATED DISPOSABLE SCALPEL NO.25
COATED DISPOSABLE SCALPEL NO.12
DISPOSABLE SCALPEL NO.15
DISPOSABLE SCALPEL NO.22
DISPOSABLE SCALPEL NO.25
DISPOSABLE SAFETY SCALPEL NO.15
NON-STERILE, BULK DISPOSABLE MINI-SCALPEL NO.11 - STAINLESS
COATED DISPOSABLE SCALPEL NO.23
DISPOSABLE SAFETY SCALPEL NO.10
DISPOSABLE SCALPEL NO.23
DISPOSABLE SAFETY SCALPEL NO.25
COATED DISPOSABLE SCALPEL NO.24
COATED DISPOSABLE SCALPEL NO.11
DISPOSABLE SCALPEL NO.11
COATED DISPOSABLE SCALPEL NO.15
DISPOSABLE SCALPEL NO.20
COATED DISPOSABLE SCALPEL NO.20
DISPOSABLE SCALPEL NO.21
COATED DISPOSABLE SCALPEL NO.21
DISPOSABLE SCALPEL NO.24
DISPOSABLE SAFETY SCALPEL NO.20
DISPOSABLE SAFETY SCALPEL NO.23
Establishment Types
Manufacture Medical Device