FDA Registration
Active
🇺🇸 United States
Seiler Instrument & Mfg. Co.,Inc.
Reg #: 1927430
·
FEI: 1927430
·
Expires 2026
Products
5
Proprietary Names
23
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Seiler Instrument & Mfg. Co.,Inc.
- Registration Number
- 1927430
- FEI Number
- 1927430
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3433 Tree Court Industrial Blvd
- City
- Saint Louis
- State
- MO
- ZIP
- 63122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101141
Owner / Operator
- Firm Name
- Seiler Instrument & Mfg. Co., Inc.
- Operator Number
- 1927430
- Address
- 3433 Tree Court Industrial Blvd., --
- City
- Saint Louis
- State
- MO
- Postal Code
- 63122
- Country
- US
- Correspondent
- Jessica - Wessel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | HEX | Class 2 | Obstetrics/Gynecology | No | 2010-11-05 |
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2010-12-21 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 1992-06-30 |
| Lamps, Microscope | KEG | Class 1 | Pathology | No | 1992-06-30 |
| Light, Microscope | IBJ | Class 1 | Pathology | No | 1992-06-30 |
Proprietary Names
Model 935 Series Colposcope
Model 955 Series Colposcope
Model 985 Series Colposcope
TITANIUM LOUPES
SLIM SPORT LOUPES
SPORT LOUPES
LED LOUPE LIGHT
ALPHA AIR 6 ENT
ALPHA AIR 6 DENTAL
ALPHA AIR 3 DENTAL
ALPHA AIR 3 ENT
Evolution XR6
Seiler IQ
3D Surgical Microscope
Evolution ZOOM
Seiler Microscope Lamps
MICROLUX IV - DIGITAL CAMERA
MICROLUX IV - LED
WESTLAB III
MICROLUX IV - MOH'S
SEILERSCOPE - LIVE VIDEO
SEILERSCOPE
MICROLUX IV
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device