FDA Registration
Active
🇯🇵 Japan
Nihon Vinyl Cord Corporation - Kodama Second Factory
Reg #: 3021736577
·
FEI: 3021736577
·
Expires 2026
Products
5
Proprietary Names
173
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Nihon Vinyl Cord Corporation - Kodama Second Factory
- Registration Number
- 3021736577
- FEI Number
- 3021736577
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1404-1 Kodama, Kodama-machi
- City
- Honjo-shi Saitama
- Country
- JP
Owner / Operator
- Firm Name
- NIHON KOHDEN CORP.
- Operator Number
- 8030227
- Address
- 1-31-4 NISHIOCHIAI, SHINJUKU-KU
- City
- TOKYO
- State
- JP-13
- Postal Code
- 161-8560
- Country
- JP
US Agent
- Business Name
- Nihon Kohden America, LLC
- Contact Name
- Charlemagne Chua
- Address
- 15353 Barranca Parkway
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 3303964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2007-11-28 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-06-05 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2012-12-07 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2012-12-07 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2015-12-28 |
Proprietary Names
TL-631T3
A/NTX-DISP
TL-272T3
ZM-530PA
ZM-521PA
TL-062S
ZM-541PA
TL-271T
TL-274T
YN-990P
TL-273T3
BR-913PA
ZS-940PA
YP-504P
ZM-520PA
YP-944P
A/NTX2-POUCH
BR-916PA
ZM-531PA
TL-201T
BR-906PA
TL-271T3
TL-274T3
BR-903PA
TL-052S
ZM-540PA
YP-503P
YP-943P
TL-220T
BLUPRO Attachment Tape
YS-111P7 (P263A)
BLUPRO Attachment Tape, YS-111P7
PSG-1100 Sleep Diagnostic System
IF-920P
YJ-671P
IF-950P
QF-921P
JT-900P
QF-908P
IF-925P
YG-211T
LIFE SCOPE® G9
YS-106P9
BSM-1753
IF-19004
IF-935P
AY-673P
A/EJ110-0010 Cable
YN-901P
QF-902P
IF-961P
IF-948P
QF-907P
IF-932P
YL-920P
DH-170P
YS-108P1
TG-101T
BSM-1773
YS-106P6
JL-500P1
JP-910P
IF-928P
IF-922P
YJ-920P
YS-105P6
YP-814P
IF-944P
YN-921P
QF-909P
JA-690PA
IF-958P
DM-190P
IF-937P
IF-957P
AY-653P
YP-812P
AA-674P
IF-912P
YP-815P
QF-911P
YJ-910P
BJ-900PA
IF-943P
IF-954P
YS-106P5
YS-105P0
DM-191P
JL-900P
IF-956P
IF-930P
YS-105P5
IF-916P
YS-108P0
YN-924P
YS-107P1
JL-631P
AY-651P
JL-630P
JA-920P
SB-170P
JA-694PA
QF-801P
DZ-170P
YS-106P8
YP-816P
YS-094P2
YN-900P
YP-813P
YS-107P9
TL-051S
YS-105P8
TL-631T1
CU-192R
A/326391 Cable
WS-960P
TL-273T
YP-811P
QF-903P
YG-111T
YS-105P7
IF-914P
YS-107P2
TG-900P
YG-101T
IF-963P
AY-631P
TG-920P
Nihon Kohden CSM-1901 Bedside Monitor
AY-671P
SC-170R
IF-946P
JP-900P
YS-104P5
JP-920P
IF-942P
AY-633P
IF-952P
A/646225 Cable
JL-639P
RY-910PA
YG-122T
IF-919P
YN-920P
JL-632P
TG-970P
YP-817P
A/CE620NK
G9-KVM/ZA
YS-106P4
TL-061S
JG-900P
YS-19003
IF-923P
JL-650P
YS-107P4
TL-272T
SB-920P
BSM-1733
YS-107P3
YS-108P2
QF-901P
YG-213T
IF-951P
YS-106P3
YS-106P7
JC-906PA
IF-917P
IF-913P
YP-810P
JT-950P
TL-535U
YN-925P
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device