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Sign in to claim this brandHeine Optotechnik GmbH & Co. KG
US
Last updated May 24, 2026
What Heine Optotechnik GmbH & Co. KG makes
Heine Optotechnik GmbH & Co. KG manufactures reusable and disposable ophthalmic and diagnostic tools, including direct and indirect ophthalmoscopes, otoscopes, laryngoscope handles, and blood pressure measurement devices like aneroid sphygmomanometers and reusable cuffs. Their portfolio also includes dermatoscopes, general physical examination sets, and wall-mounted transformers for diagnostic equipment.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- heine-na.com
- —
- —
- [email protected]
- Phone
- +1 (603) 742-7103
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 315274563
Catalogue (433)
Page 3 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Reusable Tips Vet Sanalon S | 61 mm/9 mm | FDA UDI | Class I | Active |
| visionPRO Mac 4 | 000 | FDA UDI | Class I | Active |
| Protective Lenses | FOR C 2.3 LOUPES | FDA UDI | Class I | Active |
| Soft Disposable Tips | 40 x 5 mm | FDA UDI | Class I | Active |
| HEINE BETA® 200 S LED Diagnostic Set | S | FDA UDI | Class II | Active |
| HEINE mini 3000® LED Ophthalmoscope | 000 | FDA UDI | Class II | Active |
| HEINE GAMMA® Single-tube cuff | 000 | FDA UDI | Class II | Active |
| HEINE K180® F.O. Otoscope | 166 | FDA UDI | Class I | Active |
| Protective Lenses | FOR HR LOUPES | FDA UDI | Class I | Active |
| HEINE mini 3000® F.O. Diagnostic Set | 000 | FDA UDI | Class II | Active |
| Xp Disposable Laryngoscope Blade Mac | 3 | FDA UDI | Class I | Active |
| HEINE mini 3000® LED F.O. Diagnostic Set | 000 | FDA UDI | Class II | Active |
| HEINE UniSpec® Disposable Tubes | 000 | FDA UDI | Class II | Active |
| Mini3000 Led | 2,5 V WITH SCALE | FDA UDI | Class I | Active |
| Gamma G5 | 000 | FDA UDI | Class II | Active |
| Hsl150 Loupe Attachment | 000 | FDA UDI | Class I | Active |
| Heine Omega®500 | L | FDA UDI | Class II | Active |
| Cuff Gamma G7/G5/Gp | ADULT LARGE | FDA UDI | Class II | Active |
| Heine Gamma® Gp | 000 | FDA UDI | Class II | Active |
| Beta X Ophthalmoscope | LED | FDA UDI | Class II | Active |
| Gamma Gp | 000 | FDA UDI | Class II | Active |
| Xp Disposable Laryngoscope Blade Mac | 4 | FDA UDI | Class I | Active |
| HEINE BETA® 200 Diagnostic Set | TL | FDA UDI | Class II | Active |
| Short F.o. Led Laryngoscope Handle | 4 NT | FDA UDI | Class I | Active |
| Heine Beta® 200 S Led | 000 | FDA UDI | Class II | Active |
| Standard F.o. Laryngoscope Handle | 3,5 V | FDA UDI | Class I | Active |
| Omega 500 Led | 000 | FDA UDI | Class II | Active |
| Ear Light | 000 | FDA UDI | Class I | Active |
| Heine Gamma® | .1 | FDA UDI | Class II | Active |
| Heine Omega®500 | L | FDA UDI | Class II | Active |
| HEINE EN 200® Diagnostic Center | 166 | FDA UDI | Class II | Active |
| Classic+ Laryngoscope Blade Wis | 1 | FDA UDI | Class I | Active |
| Loupelight 2 | 000 | FDA UDI | Class I | Active |
| El3 Led | 000 | FDA UDI | Class I | Active |
| Reusable Specula Sanalon S | 4,5 mm | FDA UDI | Class I | Active |
| G100 | 2,5 V | FDA UDI | Class I | Active |
| HEINE BETA® 200 Diagnostic Set | 000 | FDA UDI | Class II | Active |
| Lambda 100 | 2,5 V Scale 1 | FDA UDI | Class I | Active |
| Heine Gamma® G5 | 166 | FDA UDI | Class II | Active |
| Heine Gamma® | 166 | FDA UDI | Class II | Active |
| HEINE GAMMA® Twin-tube cuff | 000 | FDA UDI | Class II | Active |
| Heine Omega®500 | L | FDA UDI | Class II | Active |
| Short F.o. Led Laryngoscope Handle | 2,5 NiMH | FDA UDI | Class I | Active |
| HEINE® FO Anoscopes with annular FO Illumination | 000 | FDA UDI | Class II | Active |
| DELTAone | ROSE/WHITE | FDA UDI | Class I | Active |
| Xp Disposable Laryngoscope Blade Miller | 3 | FDA UDI | Class I | Active |
| C 2.3 | 450 mm | FDA UDI | Class I | Active |
| Heine Omega®500 Led Unplugged | 1LS | FDA UDI | Class II | Active |
| Beta 400 Otoscope | 2,5 V | FDA UDI | Class I | Active |
| HEINE AllSpec® Disposable Tips | 166 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
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Importers
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Heine Optotechnik Gmbh & Co. Kg. GILCHING Bavaria · DE FEI 1000379039