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Sign in to claim this brandSOPRO-COMEG GmbH
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 2 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Scissors | 393 310 250 | FDA UDI | Class II | Active |
| Scissors | 391 270 022 | FDA UDI | Class II | Active |
| Ureterorenoscope | 186 405 001BC001 | FDA UDI | Class II | Active |
| Handle for sinuscopy | 191 270 000 | FDA UDI | Class II | Active |
| Sinuscope | 161 401 812BC001 | FDA UDI | Class II | Active |
| Biopsy forceps | 393 320 207 | FDA UDI | Class II | Active |
| Resectoscopy sheath | 195 810 101 | FDA UDI | Class II | Active |
| Bipolar HF cable | 390 803 000 | FDA UDI | Class II | Active |
| Obturator | 191 241 086BC | FDA UDI | Class II | Active |
| Grasping forceps | 393 920 078 | FDA UDI | Class II | Active |
| Sinuscope | 161 401 810BC001 | FDA UDI | Class II | Active |
| Urethrotomy sheath | 195 110 050 | FDA UDI | Class II | Active |
| Veress insufflation needle | 391 120 150 | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 070 | FDA UDI | Class II | Active |
| Resectoscopy sheath | 195 030 501 | FDA UDI | Class II | Active |
| Grasping forceps | 393 920 005 | FDA UDI | Class II | Active |
| Biopsy forceps | 393 510 107 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 036 | FDA UDI | Class II | Active |
| Electrode | 195 400 101 C | FDA UDI | Class II | Active |
| Scissors | 391 350 113 | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 035 | FDA UDI | Class II | Active |
| Biopsy forceps | 393 330 206 | FDA UDI | Class II | Active |
| Trocar | 191 120 910 | FDA UDI | Class II | Active |
| Grasping forceps | 394 520 009 | FDA UDI | Class II | Active |
| Hysteroscopy obturator | 191 293 046BC | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 129 | FDA UDI | Class II | Active |
| Hysteroscopy obturator | 191 403 046 | FDA UDI | Class II | Active |
| Ureterorenoscope | 186 403 001BC001 | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 042 | FDA UDI | Class II | Active |
| Suction-irrigation-tube | 191 270 105 | FDA UDI | Class II | Active |
| Obturator | 199 075 000BC | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 007 | FDA UDI | Class II | Active |
| Scissors | 393 310 103 | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 005BC | FDA UDI | Class II | Active |
| Cystoscopy instrument | 395 700 030 | FDA UDI | Class II | Active |
| Electrode | 395 400 013 | FDA UDI | Class II | Active |
| Grasping forceps | 394 510 036 | FDA UDI | Class II | Active |
| Grasping forceps | 390 700 440 | FDA UDI | Class II | Active |
| Thoracoscope | 162 101 702BC001 | FDA UDI | Class II | Active |
| Grasping forceps | 393 920 273 | FDA UDI | Class II | Active |
| Trocar sleeve | 191 051 120 | FDA UDI | Class II | Active |
| Stone basket | 395 400 101 | FDA UDI | Class II | Active |
| Grasping forceps | 393 930 108 | FDA UDI | Class II | Active |
| Resectoscopy working element | 195 020 050 | FDA UDI | Class II | Active |
| Electrode | 195 400 101 | FDA UDI | Class II | Active |
| Grasping forceps | 393 930 201 | FDA UDI | Class II | Active |
| Cystoscopy instrument | 395 400 103 | FDA UDI | Class II | Active |
| Resectoscopy sheath | 199 040 530BC | FDA UDI | Class II | Active |
| Ureterorenoscope | 186 406 001 | FDA UDI | Class II | Active |
| Grasping forceps | 393 330 124 | FDA UDI | Class II | Active |
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