FDA Registration
Active
🇯🇵 Japan
NEITZ INSTRUMENTS COMPANY, LTD.
Reg #: 8043512
·
FEI: 3002807701
·
Expires 2026
Products
12
Proprietary Names
38
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- NEITZ INSTRUMENTS COMPANY, LTD.
- Registration Number
- 8043512
- FEI Number
- 3002807701
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4F ICHIBANCHO COURT, 15-21, ICHIBANCHO,
- City
- CHIYODA-KU Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K942712
Owner / Operator
- Firm Name
- NEITZ INSTRUMENTS CO.LTD.
- Operator Number
- 9002089
- Address
- 4F ICHIBANCHO COURT, 15-21, ICHIBANCHO
- City
- CHIYODA-KU
- State
- Tokyo
- Postal Code
- 102-0082
- Country
- JP
- Correspondent
- Takashi Terui
US Agent
- Business Name
- Qserve Group US, Inc.
- Contact Name
- Mindy McCann
- Address
- 350 S. Main Street Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2013-09-19 |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | Class 1 | Ophthalmic | No | 1995-04-28 |
| Anomaloscope | HIW | Class 1 | Ophthalmic | No | 1995-04-28 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 1995-06-28 |
| Retinoscope, Battery-Powered | HKM | Class 1 | Ophthalmic | No | 1995-04-13 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 1995-05-17 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2018-10-28 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 1994-05-26 |
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 1995-06-09 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 1994-05-26 |
| Transilluminator, Battery-Powered | HJN | Class 1 | Ophthalmic | No | 1994-05-26 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2014-06-23 |
Proprietary Names
IO-a; IO-a LED
Neitz Contact Gauge CGX-3 LED, CGX-4 LED; Neitz Contact Gauge CGX-3, CGX-4
NEITZ ANOMALOSCOPE
Anomaloscope OT-II
OPHTHALMOSCOPE, AC-POWERED
A COMPONENT OF HALOGEN DIAGNOSTIC S; BXX-12345; ET BXX-12345
RX-3, RX-3A, RX-RC, RX-3SP, RX-3ASP, RX-RCSP, RX3LED, RX3ALED, RX3SPLED, RX3ASPLED
MULTIPLE
RXRCLED, RXRCSPLED, RXRCUSBLED, RXRCUSBSPLED
FO
A COMPONENT OF HALOGEN DIAGNOSTIC SET BX-12345FO; BX-134FO
-34FO
Otoscope -34FO
Otoscope FO
IO-a LED; IO-a LED CAMERA
IO- LED, IO- LED CAMERA
DOCTOR LIGHT DL; MEDICOSPOT MS
Halogen Medicospot MS-H
BXa-13, BXa-13A, BXa-RC, BXa13LED, BXa13ALED, BX?13RXLED, BX?13ARXLED, BX?13RXSPLED, BX?13ARXSPLED
Neitz Halogen Ophthalmoscope BXa-13
BXPlus-13, BXPlus-13A
BXaRCLED, BXaRCUSBLED, BXaRCRXLED,BXaRCUSBRXLED
BXa-13, BXa-13A, BXa-RC, BXa13LED, BXa13ALED, BXa13RXLED, BXa13ARXLED, BXa13RXSPLED, BXa13ARXSPLED
HALOGEN OPHTHALMO-O
Halogen Ophthalmoscope BXa-RC
TBLS-2S, TBLS-2N
BLS-1, BLS-2, BLS-3, BLD-3, BLP-4, BLP-6
TBLS-2, TBLD-3, TBLP-4
LOUPE, BINOCULAR, LOW POWER
BTL-2S, BTL-2N
TRANSILLUMINATOR MSII
Spot Illuminator NSI-MINI
HEADLAMP, OPERATING, BATTERY-OPERATED
Spot Illuminator NSI-X
Spot Illuminator NSI-III
GH
Halogn Pocket Ophthalmoscope GH
OPHTHALMOSCOPE, BATTERY-POWERED
Establishment Types
Manufacture Medical Device