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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 4 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Closed Specula Sanalon S | 4,5 mm | FDA UDI | Class I | Active |
| HEINE AllSpec® Disposable Tips | 166 | FDA UDI | Class I | Active |
| Contact Plate Mini3000 | STANDARD WITH SCALE | FDA UDI | Class I | Active |
| HEINE BETA® 200 Desk Set | TL | FDA UDI | Class II | Active |
| HEINE AllSpec® Disposable Tips | 166 | FDA UDI | Class I | Active |
| HEINE BETA® 400 Diagnostic Set | 166 | FDA UDI | Class II | Active |
| Slim F.o. Led Laryngoscope Handle | 4 NT | FDA UDI | Class I | Active |
| Short F.o. Laryngoscope Handle | BATTERY HANDLE | FDA UDI | Class I | Active |
| Heine Gamma® Xxl Lf | 166 | FDA UDI | Class II | Active |
| Tongue Blade Holder Disposable Blade | 3,5 V | FDA UDI | Class I | Active |
| HEINE EN 200® Diagnostic Center | 166 | FDA UDI | Class II | Active |
| Soft Disposable Tips | 40 x 3 mm | FDA UDI | Class I | Active |
| Mini3000 | 2,5 V WITH SCALE | FDA UDI | Class I | Active |
| HEINE GAMMA® Twin-tube cuff | 000 | FDA UDI | Class II | Active |
| Closed Specula Sanalon S | 3,5 mm | FDA UDI | Class I | Active |
| HEINE® EN 200 Wall Transformer | 166 | FDA UDI | Class II | Active |
| Heine Gamma® | 166 | FDA UDI | Class II | Active |
| DISPOSABLE TIPS ALLSPEC 2, 5 mm | 250 pcs. | FDA UDI | Class I | Active |
| Combi Lamp Mini3000 | 000 | FDA UDI | Class I | Active |
| HEINE diSTANCE | 000 | FDA UDI | Class I | Active |
| HEINE® Disposable Hygiene Filters | 000 | FDA UDI | Class II | Active |
| Slit Metal Specula Vet | 90 mm | FDA UDI | Class I | Active |
| visionPRO HR1 Mac | 000 | FDA UDI | Class I | Active |
| Standard F.o. Led Laryngoscope Handle | 4 NT | FDA UDI | Class I | Active |
| HEINE® EN 200 Diagnostic Centre | 166 | FDA UDI | Class II | Active |
| HEINE EN 100® Diagnostic Center | TL | FDA UDI | Class II | Active |
| Mini-C | LED | FDA UDI | Class I | Active |
| HEINE EN 100® Diagnostic Center | TL | FDA UDI | Class II | Active |
| Tongue Blade Holder | 2,5 V | FDA UDI | Class I | Active |
| Ophthalmoscopy Lens A.r. | 50 mm | FDA UDI | Class I | Active |
| Beta 200 S Led Ophthalmoscope | 000 | FDA UDI | Class II | Active |
| Closed Specula Sanalon S | 2,8 mm | FDA UDI | Class I | Active |
| Heine Beta® 200 S | 000 | FDA UDI | Class II | Active |
| Beta 400 Otoscope | 3,5 V TL | FDA UDI | Class I | Active |
| Heine Gamma® | 000 | FDA UDI | Class II | Active |
| G100 Led | 000 | FDA UDI | Class I | Active |
| Tongue Blade Holder Mini3000 | 2,5 V | FDA UDI | Class I | Active |
| Beta 200 Otoscope | 3,5 V | FDA UDI | Class I | Active |
| Standard F.o. Laryngoscope Handle | 3,5 V NiMH | FDA UDI | Class I | Active |
| Heine Gamma® | 000 | FDA UDI | Class II | Active |
| Closed Specula Sanalon S | 2,2 mm | FDA UDI | Class I | Active |
| OMEGA 600 wired | 000 | FDA UDI | Class II | Active |
| HEINE EN 100® Diagnostic Center | TL | FDA UDI | Class II | Active |
| HEINE BETA® 200 LED Desk Set | 000 | FDA UDI | Class II | Active |
| Beta 400 Led F.o. Otoscope | 2,5 V | FDA UDI | Class I | Active |
| Heine Beta® 200 S | 310 | FDA UDI | Class II | Active |
| Xp Disposable Laryngoscope Handle | 000 | FDA UDI | Class I | Active |
| Closed Metal Specula Vet | 90 mm | FDA UDI | Class I | Active |
| visionPRO Mac 3 | 000 | FDA UDI | Class I | Active |
| Mini3000 F.o. | 2,5 V | FDA UDI | Class I | Active |
Related Companies
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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