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Sign in to claim this brandTekno Medical Optik-Chirurgie GmbH & Co.
US
Last updated May 23, 2026
What Tekno Medical Optik-Chirurgie GmbH & Co. makes
Tekno Medical Optik-Chirurgie GmbH & Co. manufactures reusable surgical instruments, including tooth extraction forceps, general-purpose surgical scissors, and suturing needle holders. Their portfolio also covers specialized tools like corneal scissors, orthopaedic rongeurs, and dental dressing forceps, designed for precision in soft-tissue manipulation and joint/limb procedures. Additional items include suture scissors and reusable surgical forceps tailored for various medical applications.
The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. These instruments are listed via the FDA’s 510(k) and UDI (Unique Device Identification) systems, ensuring compliance with US medical device regulations. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Tekno Medical Optik-Chirurgie GmbH & Co. manufacture?
Tekno Medical Optik-Chirurgie GmbH & Co. specializes in reusable surgical instruments. Their portfolio includes general-purpose tools like tooth extraction forceps, general-purpose surgical scissors, and suturing needle holders. They also produce specialized instruments such as corneal scissors, orthopaedic joint/limb rongeurs, dental dressing forceps, and suture scissors. These devices are designed for precision in procedures ranging from soft-tissue manipulation to orthopaedic and dental applications.
Where is Tekno Medical Optik-Chirurgie GmbH & Co. based?
The company operates from the United States. While the name suggests a European origin (GmbH & Co. is a German legal structure), their regulatory filings and device listings are submitted through the FDA, confirming their primary operational base in the US.
Which regulatory registries or databases list Tekno Medical Optik-Chirurgie GmbH & Co.’s devices?
Tekno Medical Optik-Chirurgie GmbH & Co.’s devices are listed in the FDA’s 510(k) premarket notification system and the Unique Device Identification (UDI) database. These registries ensure compliance with US medical device regulations and provide transparency on authorised products.
How are Tekno Medical Optik-Chirurgie GmbH & Co.’s devices classified under FDA regulations?
Tekno Medical Optik-Chirurgie GmbH & Co.’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II instruments—such as some surgical scissors or forceps—may require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and regulatory history.
Why do some of Tekno Medical Optik-Chirurgie GmbH & Co.’s devices require FDA 510(k) clearance?
The FDA’s 510(k) premarket notification process applies to devices that are not exempt from regulatory oversight and are determined to be substantially equivalent to a legally marketed predicate device. Since Tekno Medical Optik-Chirurgie GmbH & Co.’s instruments—such as reusable surgical scissors or forceps—are not automatically exempt (e.g., they are not low-risk items like bandages), they must demonstrate equivalence to existing authorised devices to ensure safety and effectiveness before entering the US market.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (108)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tekno® | 70120-88R | FDA UDI | Class I | Active |
| Tekno® | 11200-12 | FDA UDI | Class I | Active |
| Tekno® | 8250-10 | FDA UDI | Class I | Active |
| Tekno® | 70100-46LX | FDA UDI | Class I | Active |
| Tekno® | 70100-18. | FDA UDI | Class I | Active |
| Tekno® | 17080-16 | FDA UDI | Class I | Active |
| Tekno® | 24606-01 | FDA UDI | Class I | Active |
| Tekno® | 8582-16 | FDA UDI | Class I | Active |
| Tekno® | 70120-10S | FDA UDI | Class I | Active |
| Tekno® | 20536-17 | FDA UDI | Class I | Active |
| Tekno® | 11210-12 | FDA UDI | Class I | Active |
| Tekno® | 8356-18 | FDA UDI | Class I | Active |
| Tekno® | 20710-14D | FDA UDI | Class I | Active |
| Tekno® | 9923-13SU | FDA UDI | Class I | Active |
| Tekno® | Z0000122838 | FDA UDI | Class I | Active |
| Tekno® | 70120-23 | FDA UDI | Class I | Active |
| Tekno® | 70120-69 | FDA UDI | Class I | Active |
| Tekno® | 8035-13 | FDA UDI | Class I | Active |
| Tekno® | 12041-14 | FDA UDI | Class I | Active |
| Tekno® | 71028-13 | FDA UDI | Class I | Active |
| Tekno® | 8857-17 | FDA UDI | Class I | Active |
| Tekno® | 8462-16 | FDA UDI | Class I | Active |
| Tekno® | 70120-99A* | FDA UDI | Class I | Active |
| Tekno® | 8463-16SU | FDA UDI | Class I | Active |
| Tekno® | 12051-14 | FDA UDI | Class I | Active |
| Tekno® | 70064-05 | FDA UDI | Class I | Active |
| Tekno® | 70120-201 | FDA UDI | Class I | Active |
| Tekno® | 70075-12 | FDA UDI | Class I | Active |
| Tekno® | 70120-99C* | FDA UDI | Class I | Active |
| Tekno® | 12061-14 | FDA UDI | Class I | Active |
| Tekno® | 12805-13 | FDA UDI | Class I | Active |
| Tekno® | 9434-11SU | FDA UDI | Class I | Active |
| Tekno® | 24605-12 | FDA UDI | Class I | Active |
| Tekno® | 9434-11 | FDA UDI | Class I | Active |
| Tekno® | 52131-14 | FDA UDI | Class I | Active |
| Tekno® | 70100-18 | FDA UDI | Class I | Active |
| Tekno® | 12001-10 | FDA UDI | Class I | Active |
| Tekno® | 70120-151S. | FDA UDI | Class I | Active |
| Tekno® | 10500-12 | FDA UDI | Class I | Active |
| Tekno® | 70105-03MD | FDA UDI | Class I | Active |
| Tekno® | 8356-30 | FDA UDI | Class I | Active |
| Tekno® | 9922-13 | FDA UDI | Class I | Active |
| Tekno® | 70100-74 | FDA UDI | Class I | Active |
| Tekno® | 20036-14 | FDA UDI | Class I | Active |
| Tekno® | 20503-14 | FDA UDI | Class I | Active |
| Tekno® | 8323-14 | FDA UDI | Class I | Active |
| Tekno® | 9432-11SU | FDA UDI | Class I | Active |
| Tekno® | 12061-16 | FDA UDI | Class I | Active |
| Tekno® | 8272-14 | FDA UDI | Class I | Active |
| Tekno® | 9522-12.* | 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.
- Tekno Medical Optik-Chirurgie Gmbh TUTTLINGEN-Nendingen Baden-Wurttemberg · DE FEI 3002808335