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US
Last updated May 23, 2026
What SOPRO-COMEG GmbH makes
SOPRO-COMEG GmbH manufactures reusable rigid endoscopic instruments, including tissue manipulation forceps, endoscope sheaths, obturators, and laparoscopic trocar blades. Their portfolio also includes reusable electrosurgical handpieces, urethral bougies, rigid optical laparoscopes, and endoscopic biopsy forceps, as well as single-use devices like Veress insufflation needles and urology syringes. These tools are designed for bronchoscopy, arthroscopy, cystoscopy, and other minimally invasive procedures.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in the United States, adhering to applicable medical device standards and requirements.
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 SOPRO-COMEG GmbH primarily manufacture?
SOPRO-COMEG GmbH specializes in reusable rigid endoscopic instruments, including forceps for tissue manipulation and biopsy, endoscope sheaths, obturators, and laparoscopic trocar blades. Their portfolio also covers reusable electrosurgical handpieces, urethral bougies, and rigid optical laparoscopes. Additionally, they produce single-use items like Veress insufflation needles and urology syringes, catering to procedures such as bronchoscopy, arthroscopy, and cystoscopy. These devices are designed for minimally invasive surgical applications.
Where is SOPRO-COMEG GmbH based, and what region do their devices target?
SOPRO-COMEG GmbH is based in the United States. Their devices are specifically intended for use within this region, where they must comply with applicable FDA regulations and standards. The company’s focus on reusable and single-use instruments aligns with the regulatory requirements of the US market.
Which regulatory registries or databases list SOPRO-COMEG GmbH’s devices?
SOPRO-COMEG GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II medical devices, which are subject to stricter controls than Class I devices due to their higher risk. Listing in the UDI database is a requirement for compliance with FDA regulations.
How are SOPRO-COMEG GmbH’s devices classified under FDA regulations?
SOPRO-COMEG GmbH’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. Examples include reusable endoscopic instruments and electrosurgical tools, which require validation of performance, labeling, and manufacturing processes to meet regulatory standards.
What distinguishes SOPRO-COMEG GmbH’s reusable devices from single-use alternatives?
SOPRO-COMEG GmbH’s reusable devices—such as rigid endoscopic forceps, endoscope sheaths, and electrosurgical handpieces—are designed for repeated use with proper sterilization between procedures. Unlike single-use items like Veress insufflation needles or urology syringes, reusable devices must undergo rigorous cleaning, inspection, and sterilization protocols to maintain safety and functionality. This approach balances cost efficiency with compliance to infection control standards, particularly in endoscopic and laparoscopic surgeries.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 507185952
Catalogue (1770)
Page 6 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Grasping forceps | 393 330 001 | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 011 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 019 | FDA UDI | Class II | Active |
| Urethrotomy knife | 397 500 038 | FDA UDI | Class II | Active |
| Punch | 391 305 006 | FDA UDI | Class II | Active |
| Laparoscope | 162 103 250BC001 | FDA UDI | Class II | Active |
| Bipolar electrode | 392 993 127 | FDA UDI | Class II | Active |
| Needle holder | 393 550 146 | FDA UDI | Class II | Active |
| Adaptable tube | 191 400 110 | FDA UDI | Class II | Active |
| Needle holder | 393 540 147 | FDA UDI | Class II | Active |
| Monopolar electrode | 392 999 610 | FDA UDI | Class II | Active |
| Obturator | 195 075 020BC | FDA UDI | Class II | Active |
| Arthroscopy sheath | 191 501 757 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 105 | FDA UDI | Class II | Active |
| Trocar | 195 200 200BC | FDA UDI | Class II | Active |
| Urethrotomy knife | 397 500 037BC | FDA UDI | Class II | Active |
| Grasping forceps | 394 520 078 | FDA UDI | Class II | Active |
| Resectoscopy sheath | 199 040 515 | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 070 | FDA UDI | Class II | Active |
| Grasping forceps | 394 520 075 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 018 | FDA UDI | Class II | Active |
| Suction-irrigation-handle | 191 500 110BC | FDA UDI | Class II | Active |
| Scissors | 393 360 251 | FDA UDI | Class II | Active |
| Resectoscopy sheath | 195 400 010BC | FDA UDI | Class II | Active |
| Urology Evacuator | 199 090 500BC | FDA UDI | Class II | Active |
| Biopsy forceps | 393 520 115 | FDA UDI | Class II | Active |
| Electrode | 395 400 023 | FDA UDI | Class II | Active |
| Hysteroscope | 163 282 990 | FDA UDI | Class II | Active |
| Cystoscopy adaptor | 198 050 300 | FDA UDI | Class II | Active |
| Bipolar electrode | 392 993 009 | FDA UDI | Class II | Active |
| Grasping forceps | 393 920 145 | FDA UDI | Class II | Active |
| Hysteroscope | 163 412 980BC001 | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 008 | FDA UDI | Class II | Active |
| Grasping forceps | 394 530 008 | FDA UDI | Class II | Active |
| Punch | 393 100 214 | FDA UDI | Class II | Active |
| Hysteroscopy sheath | 191 203 060BC | FDA UDI | Class II | Active |
| Cystoscope | 165 293 000 | FDA UDI | Class II | Active |
| Punch | 397 100 234 | FDA UDI | Class II | Active |
| Bronchoscope | 164 044 510BC001 | FDA UDI | Class II | Active |
| Ureterorenoscope | 186 069 001 | FDA UDI | Class II | Active |
| Forceps | 395 400 138 | FDA UDI | Class II | Active |
| Suction-irrigation-tube | 191 270 100 | FDA UDI | Class II | Active |
| Needle holder | 393 540 148 | FDA UDI | Class II | Active |
| Grasping forceps | 394 530 030 | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 080 | FDA UDI | Class II | Active |
| Cystoscopy obturator | 196 040 500 | FDA UDI | Class II | Active |
| Resectoscopy sheath | 195 800 100 | FDA UDI | Class II | Active |
| Grasping forceps | 394 510 001 | FDA UDI | Class II | Active |
| Trocar sleeve | 191 120 090 | FDA UDI | Class II | Active |
| Electrode | 395 400 014 | FDA UDI | Class II | Active |
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