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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 2 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Heine Omega®500 | 000 | FDA UDI | Class II | Active |
| HEINE EN 100® Diagnostic Center | 000 | FDA UDI | Class II | Active |
| Heine Omega®500 Led | 000 | FDA UDI | Class II | Active |
| Xp Disposable Laryngoscope Blade Miller | 1 | FDA UDI | Class I | Active |
| K 180 Led Ophthalmoscope | 3,5 | FDA UDI | Class II | Active |
| HEINE BETA® 200 Diagnostic Set | 000 | FDA UDI | Class II | Active |
| HEINE mini 3000® LED Ophthalmoscope | 000 | FDA UDI | Class II | Active |
| HEINE EN 100® Diagnostic Center | 000 | FDA UDI | Class II | Active |
| Polarisation Filter P2 Loupelight | 000 | FDA UDI | Class I | Active |
| HEINE K180® Ophthalmoscope | 000 | FDA UDI | Class II | Active |
| Clip Lamp Mini3000 | 000 | FDA UDI | Class I | Active |
| HEINE XHL® Xenon Halogen Bulbs | 166 | FDA UDI | Class II | Active |
| Closed Specula Sanalon S | 5,5 mm | FDA UDI | Class I | Active |
| Lambda 100 | 3,5 V Scale 1 | FDA UDI | Class I | Active |
| HEINE UniSpec® Disposable Tubes | 000 | FDA UDI | Class II | Active |
| Standard F.o. Laryngoscope Handle | BATTERY HANDLE | FDA UDI | Class I | Active |
| HEINE EN 200® Diagnostic Center | 166 | FDA UDI | Class II | Active |
| Heine Omega®500 | L | FDA UDI | Class II | Active |
| Disposable Tongue Blade | 000 | FDA UDI | Class I | Active |
| C 2.3 K | 340 mm | FDA UDI | Class I | Active |
| Reusable Specula Sanalon S | 2,2 mm | FDA UDI | Class I | Active |
| Slim F.o. Laryngoscope Handle | BATTERY HANDLE | FDA UDI | Class I | Active |
| HEINE BETA® 200 Diagnostic Set | TL | FDA UDI | Class II | Active |
| Heine Gamma® G7 | 000 | FDA UDI | Class II | Active |
| HEINE UniSpec® Disposable Tubes | 000 | FDA UDI | Class II | Active |
| Heine Gamma® | 166 | FDA UDI | Class II | Active |
| Contact Plate Delta 30 | SMALL | FDA UDI | Class I | Active |
| HEINE BETA® 200 Ophthalmoscope | 166 | FDA UDI | Class II | Active |
| HEINE® Anoscope Instrument Kit | 000 | FDA UDI | Class II | Active |
| Heine Gamma® | 166 | FDA UDI | Class II | Active |
| Classic+ Laryngoscope Blade Wis | 2 | FDA UDI | Class I | Active |
| Mini3000 | 2,5 V WITHOUT SCALE | FDA UDI | Class I | Active |
| Heine Gamma® | 000 | FDA UDI | Class II | Active |
| Heine Gamma® | .1 | FDA UDI | Class II | Active |
| HEINE mini 3000® F.O. Diagnostic Set | 000 | FDA UDI | Class II | Active |
| HEINE BETA® 200 LED Desk Set | 000 | FDA UDI | Class II | Active |
| G100 | 3,5 V | FDA UDI | Class I | Active |
| Hr | 2.5 x 420 mm | FDA UDI | Class I | Active |
| Instrument Head For Unispec Tubes | 000 | FDA UDI | Class II | Active |
| DISPOSABLE TIPS ALLSPEC 2, 5 mm | 10 boxes | FDA UDI | Class I | Active |
| Beta 200 Ophthalmoscope | 2,5 V | FDA UDI | Class II | Active |
| Cuff Gamma Xxl Lf | ADULT LARGE | FDA UDI | Class II | Active |
| Contact Plate Mini3000 | SMALL | FDA UDI | Class I | Active |
| Heine Gamma® | .1 | FDA UDI | Class II | Active |
| Delta 20t | WITH SCALE | FDA UDI | Class I | Active |
| Classic+ Laryngoscope Blade Mac | 4 | FDA UDI | Class I | Active |
| Xp Disposable Laryngoscope Blade Miller | 4 | FDA UDI | Class I | Active |
| HEINE GAMMA® GP Practice Kit | 000 | FDA UDI | Class II | Active |
| HEINE mini 3000® LED F.O. Diagnostic Set | S | FDA UDI | Class II | Active |
| Finoff Transilluminator | 2,5 V | FDA UDI | Class II | Active |
Related Companies
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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