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Sign in to claim this brandTROKAMED GmbH
US
Last updated May 24, 2026
What TROKAMED GmbH makes
Trokamed GmbH manufactures reusable laparoscopic access cannulas, endoscopic-access dilators, and rigid endoscopic tissue manipulation forceps for surgical procedures. Their portfolio also includes single-use uterine manipulators, a uterine elevator, and specialized instruments like urethrotomes and rigid endoscope obturators. These devices are designed for minimally invasive and endoscopic applications, supporting tissue manipulation and access in various surgical settings. The company also produces tissue morcellation systems for fragmenting tissue during procedures.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions documented through 510(k) premarket notifications and Unique Device Identifiers (UDIs). These products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device authorization requirements. Trokamed GmbH operates from the United States, adhering to domestic regulatory standards for their product portfolio.
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 Trokamed GmbH manufacture?
Trokamed GmbH specializes in reusable and single-use devices for minimally invasive and endoscopic surgeries. Their portfolio includes laparoscopic access cannulas, endoscopic-access dilators, rigid endoscopic tissue manipulation forceps, a uterine elevator, and specialized tools like urethrotomes and rigid endoscope obturators. They also produce tissue morcellation systems for fragmenting tissue during procedures, ensuring access and manipulation in surgical settings.
Where is Trokamed GmbH based, and how does this affect their regulatory compliance?
Trokamed GmbH is based in the United States, which means their devices must comply with U.S. regulatory requirements. Since their products fall under FDA classifications—primarily Class I and Class II—they undergo authorization processes like 510(k) premarket notifications and Unique Device Identifier (UDI) registration to ensure adherence to U.S. medical device standards.
Which regulatory registries or databases list Trokamed GmbH’s devices?
Trokamed GmbH’s devices are documented in the FDA’s regulatory databases, specifically through 510(k) premarket notifications and Unique Device Identifier (UDI) listings. These entries confirm their compliance with U.S. authorization requirements, ensuring transparency in their product portfolio’s regulatory status.
How are Trokamed GmbH’s devices classified under FDA regulations?
Trokamed GmbH’s devices are classified under two main FDA categories: Class I and Class II. Class I devices generally pose the lowest risk and may require less stringent regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) submissions or other premarket authorizations.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- trokamed.de
- —
- —
- [email protected]
- Phone
- +49770492440
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 341943858
Catalogue (51)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Blueendo | 20-136520 | FDA UDI | Class II | Active |
| Blueendo | 53-001020 | FDA UDI | Class II | Active |
| blueendo | 02-00091 | FDA UDI | Class II | Active |
| Trokamed | UUM00198 | FDA UDI | Class II | Active |
| Blueendo | 55-122005 | FDA UDI | Class II | Active |
| Blueendo | 04-00544 | FDA UDI | Class II | Active |
| Blueendo | 53-000032 | FDA UDI | Class II | Active |
| Blueendo | 55-000031-V2 | FDA UDI | Class II | Active |
| Trokamed | WA2PS18L | EUDAMEDFDA UDI | Class II | Active |
| Blueendo | 55-151001 | FDA UDI | Class II | Active |
| Trokamed | UUM00197 | FDA UDI | Class II | Active |
| Trokamed | WA2PS20S | FDA UDI | Class II | Active |
| Trokamed | WA2PS20L | FDA UDI | Class II | Active |
| blueendo | 02-00090 | FDA UDI | Class II | Active |
| Blueendo | 55-000321-V2 | FDA UDI | Class II | Active |
| Blueendo | 02-33109 | FDA UDI | Class II | Active |
| Blueendo | 02-33008 | FDA UDI | Class II | Active |
| Blueendo | 02-33049 | FDA UDI | Class II | Active |
| Trokamed | WA2PD18A | FDA UDI | Class II | Active |
| Blueendo | 53-000012 | FDA UDI | Class II | Active |
| Blueendo | 55-121006 | FDA UDI | Class II | Active |
| Blueendo | 02-33076 | FDA UDI | Class II | Active |
| Trokamed | DIL15006 | FDA UDI | Class I | Active |
| Blueendo | 02-33117 | FDA UDI | Class II | Active |
| Blueendo | 02-33041 | FDA UDI | Class II | Active |
| blueendo | 02-00088 | FDA UDI | Class II | Active |
| Blueendo | 02-33039US | FDA UDI | Class II | Active |
| Blueendo | 55-151006 | FDA UDI | Class II | Active |
| Blueendo | 55-152005 | FDA UDI | Class II | Active |
| Blueendo | 20-136510 | FDA UDI | Class II | Active |
| blueendo | 02-00095 | FDA UDI | Class II | Active |
| Trokamed | URE02798 | FDA UDI | Class II | Active |
| Blueendo | 55-201006 | FDA UDI | Class II | Active |
| blueendo | 02-00089 | FDA UDI | Class II | Active |
| Blueendo | 04-00543 | FDA UDI | Class II | Active |
| Blueendo | 55-202005 | FDA UDI | Class II | Active |
| Blueendo | 20-135000 | FDA UDI | Class II | Active |
| Trokamed | WA2PS18S | FDA UDI | Class II | Active |
| Blueendo | 04-00547 | FDA UDI | Class II | Active |
| Trokamed | DIL15095 | FDA UDI | Class I | Active |
| Blueendo | 55-121001 | FDA UDI | Class II | Active |
| Blueendo | 02-33103 | FDA UDI | Class II | Active |
| Blueendo | 02-33045 | FDA UDI | Class II | Active |
| blueendo | 02-00087 | FDA UDI | Class II | Active |
| Blueendo | 55-201001 | FDA UDI | Class II | Active |
| Blueendo | 53-001015 | FDA UDI | Class II | Active |
| Blueendo | 02-33106 | FDA UDI | Class II | Active |
| Trokamed Gmbh Electrosurgical Instruments & Accessories | K060232 | FDA 510(k) | Class II | Active |
| Trokamed Morcellator | K091010 | FDA 510(k) | Class II | Active |
| Trokamed Gmbh Endoscopes And Accessories | K060233 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Trokamed Gmbh GEISINGEN Baden-Wurttemberg · DE FEI 3004595684