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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 5 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iC1 | 000 | FDA UDI | Class I | Active |
| HEINE XHL® Xenon Halogen Bulbs | 166 | FDA UDI | Class II | Active |
| DELTAone CONTACT PLATE | STANDARD | FDA UDI | Class I | Active |
| HEINE GAMMA® Twin-tube cuff | 000 | FDA UDI | Class II | Active |
| Heine Omega®500 | L | FDA UDI | Class II | Active |
| Xp Disposable Laryngoscope Blade Miller | 0 | FDA UDI | Class I | Active |
| Closed Metal Specula Vet | 57 mm | FDA UDI | Class I | Active |
| HEINE BETA® 400 Diagnostic Set | 166 | FDA UDI | Class II | Active |
| HEINE BETA® 200 S Diagnostic Set | S | FDA UDI | Class II | Active |
| HEINE BETA® 200 Diagnostic Set | 166 | FDA UDI | Class II | Active |
| Insufflation Bulb | 000 | FDA UDI | Class I | Active |
| HEINE EN 100® Diagnostic Center | TL | FDA UDI | Class II | Active |
| Gamma 3.1 | 000 | FDA UDI | Class I | Active |
| HEINE EN 200® Diagnostic Center | 166 | FDA UDI | Class II | Active |
| Tip Adaptor | FOR BETA 100 | FDA UDI | Class I | Active |
| HEINE GAMMA® Single-tube cuff | 000 | FDA UDI | Class II | Active |
| HEINE GAMMA® G7 Practice Kit | 000 | FDA UDI | Class II | Active |
| HEINE UniSpec® Disposable Tubes | 000 | FDA UDI | Class II | Active |
| Reusable Tip Sanalon S | 50 x 5,0 mm | FDA UDI | Class I | Active |
| Hrp | 3.5 x 420 mm | FDA UDI | Class I | Active |
| Heine Gamma® | 166 | FDA UDI | Class II | Active |
| Classic+ Laryngoscope Blade Miller | 0 | FDA UDI | Class I | Active |
| Beta 200 Vet. Otoscope | 3,5 V | FDA UDI | Class I | Active |
| HEINE EN 100® Diagnostic Center | 000 | FDA UDI | Class II | Active |
| BETA X Otoscope | 4.2 x | FDA UDI | Class I | Active |
| Closed Metal Specula Vet | 65 mm | FDA UDI | Class I | Active |
| C 2.3 K | 450 mm | FDA UDI | Class I | Active |
| HEINE GAMMA® Single-tube cuff | 000 | FDA UDI | Class II | Active |
| Gamma 3.3 | 000 | FDA UDI | Class I | Active |
| Hrp | 4 x 340 mm | FDA UDI | Class I | Active |
| HEINE BETA® 200 Diagnostic Set | 000 | FDA UDI | Class II | Active |
| K 180 Otoscope | 3,5 V TL | FDA UDI | Class I | Active |
| HEINE® FO Anoscopes with annular FO Illumination | 000 | FDA UDI | Class II | Active |
| Heine Gamma® | 166 | FDA UDI | Class II | Active |
| Close-Up Lenses | 2.5 x 340 mm | FDA UDI | Class I | Active |
| Heine Sigma®250 | 000 | FDA UDI | Class II | Active |
| Gamma C.3 | 000 | FDA UDI | Class I | Active |
| Heine Omega®500 | L | FDA UDI | Class II | Active |
| Classic+ Laryngoscope Blade Mac | 3 | FDA UDI | Class I | Active |
| Short F.o. Laryngoscope Handle | 3,5 V NiMH | FDA UDI | Class I | Active |
| DELTAone CONTACT PLATE | SMALL | FDA UDI | Class I | Active |
| Gamma 3.2 | 000 | FDA UDI | Class I | Active |
| Heine Gamma® | 166 | FDA UDI | Class II | Active |
| HEINE UniSpec® Disposable Tubes | 000 | FDA UDI | Class II | Active |
| Beta 200 S Ophthalmoscope | 2,5 V | FDA UDI | Class II | Active |
| K 180 Ophthalmoscope | 2,5 V | FDA UDI | Class II | Active |
| HEINE UniSpec® Disposable Tubes | 000 | FDA UDI | Class II | Active |
| Heine Gamma® | 166 | FDA UDI | Class II | Active |
| Ml4 Led | 000 | FDA UDI | Class I | Active |
| Spreadable Speculum Vet | 95 mm | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
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Importers
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Notified Bodies
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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