FDA Registration
Active
🇩🇪 Germany
HEINE OPTOTECHNIK GMBH & CO. KG.
Reg #: 1000379039
·
FEI: 1000379039
·
Expires 2026
Products
22
Proprietary Names
10
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- HEINE OPTOTECHNIK GMBH & CO. KG.
- Registration Number
- 1000379039
- FEI Number
- 1000379039
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- DORNIERSTR. 6
- City
- GILCHING Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K123587
Owner / Operator
- Firm Name
- HEINE OPTOTECHNIK GMBH & CO. KG.
- Operator Number
- 9003020
- Address
- Dornierstr. 6
- City
- Gilching
- State
- Bavaria
- Postal Code
- 82205
- Country
- DE
US Agent
- Business Name
- HEINE USA Ltd.
- Contact Name
- Mary Brady
- Address
- 10 Innovation Way
- City
- Dover
- State
- NH
- ZIP
- 03820
- Country
- US
- [email protected]
- Phone
- 800 3674572 ext. 6617
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2008-06-25 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2013-03-26 |
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2013-03-05 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2007-11-12 |
| Transilluminator, Ac-Powered | HJM | Class 2 | Ophthalmic | No | 2008-04-03 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2007-11-29 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2004-06-02 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2004-06-02 |
| Stand, Instrument, Ac-Powered, Ophthalmic | HMF | Class 1 | Ophthalmic | No | 2013-01-14 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 1991-08-08 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2008-04-29 |
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2004-06-02 |
| Endoscope, Rigid | GCM | Class 2 | Gastroenterology, Urology | No | 2007-11-30 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2004-06-02 |
| Retinoscope, Battery-Powered | HKM | Class 1 | Ophthalmic | No | 2004-06-02 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2004-06-02 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2010-04-23 |
| Transilluminator, Battery-Powered | HJN | Class 1 | Ophthalmic | No | 2008-04-03 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2010-09-24 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2004-06-02 |
| Headlight, Fiberoptic Focusing | FCT | Class 2 | Ophthalmic | No | 2007-11-29 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2004-06-02 |
Proprietary Names
Various Models of Beta
Monocular, Binocular
Handheld Indirect Ophthalmoscope
K180
Direct or Indirect Ophthalmoscopes
UniSpec Disposable Tubes
Omega
mini
Sigma
Beta
Establishment Types
Manufacture Medical Device