FDA Registration
Active
🇺🇸 United States
REICHERT INC.
Reg #: 1319721
·
FEI: 1000159913
·
Expires 2026
Products
20
Proprietary Names
56
Establishment Types
4
Classifications
20
Registration Details
- Registration Name
- REICHERT INC.
- Registration Number
- 1319721
- FEI Number
- 1000159913
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3362 Walden Ave, Suite 100
- City
- DEPEW
- State
- NY
- ZIP
- 14043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070534
Owner / Operator
- Firm Name
- REICHERT INC.
- Operator Number
- 9055850
- Address
- 3362 WALDEN AVE., Suite 100
- City
- Depew
- State
- NY
- Postal Code
- 14043
- Country
- US
- Correspondent
- Richard Boerdner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2007-11-14 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2007-11-14 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2014-11-06 |
| Automated Colony Counter | KZB | Class 1 | Microbiology | No | 2012-12-14 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 1996-05-23 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2007-11-14 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2004-06-17 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2007-11-14 |
| Refractometer For Donor Testing | PSM | Class 1 | Clinical Chemistry | No | 2019-03-26 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 1996-05-23 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2024-03-27 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2006-09-18 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2012-12-04 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2006-09-18 |
| Manual Colony Counter | KZC | Class 1 | Microbiology | No | 2004-06-23 |
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2006-09-18 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2024-03-27 |
| Pupillometer, Manual | HLH | Class 1 | Ophthalmic | No | 2006-09-18 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2018-05-04 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2000-05-11 |
Proprietary Names
Ocu-Film® +
CATS Tonometer Prism
UNISTAT® Bilirubinometer
Xcel® 455 Slit Lamp
A900 Tonometer
Quebec® Digital Darkfield Colony Counter
LensChek Pro Digital Lensometer®
LensChek Plus Digital Lensometer®
CT210 Contact Tonometer
iPac® Pachymeter
Reichert Digital USG-Chek
Goldberg TS Meter
Reichert Digital Clinic-Chek
Reichert Digital VET360-Chek
Reichert VET 360 TS Meter
Model 30 Tip and Membrane Assembly for Pneumatonometer
PSL Portable Slit Lamp
Ocular Response Analyzer
Ocular Response Analyzer® G3
Refractix DSP
TS Meter DSP
Phoroptor® VRx
Phoroptor® VRx with Prism
Illuminated Phoroptor®
Ultramatic RX Master Phoroptor®
SightChek® Digital Phoroptor
ACTIVA MED
Reichert® 7CR Auto Tonometer + Corneal Response Technology®
Ocular Response Analyzer®
Tono-Pen AVIA Vet®
Tono-Pen AVIA®
TF50 Trial Frame
Model 30 Pneumatonometer
Xcel® 255 Slit Lamp
Tono-Vera® Tonometer Starter Kit, Rechargeable
Tono-Vera® Tonometer Starter Kit, AA Battery
Ocu-Dot® Tonometer Probes - 100 Count
CP-M Circular Polarizer
NearBright Illuminated Near Vision Kit
ClearChart® 4X
AcuityChek
ClearChart® 4
CP-D Circular Polarizer
ClearChart® 4P
TS75 Trial Lens Set
Quebec® Manual Darkfield Colony Counter
OS1000
Reichert® 7 Auto Tonometer
VISUPLAN 500 Tonometer
IDRA
DSLC 200
DEM 100
PDM Digital PD Meter
MiiS Horus+ Scope DEA 200
OptoChek Plus Auto Refractor Keratometer
RK600 Auto Refractor/Keratometer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device