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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 5 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Obturator | 191 401 802BC | FDA UDI | Class II | Active |
| Cystoscopy obturator | 196 070 300 | FDA UDI | Class II | Active |
| Laparoscope | 162 053 042BC001 | FDA UDI | Class II | Active |
| Working element | 198 010 010BC | FDA UDI | Class II | Active |
| Sinuscope | 161 401 820 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 142 | FDA UDI | Class II | Active |
| Suction-irrigation-tube | 191 400 110BC | FDA UDI | Class II | Active |
| Nephroscopy sheath | 195 800 035BC | FDA UDI | Class II | Active |
| Resectoscopy sheath | 199 040 540 | FDA UDI | Class II | Active |
| Forceps | 395 400 137 | FDA UDI | Class II | Active |
| Monopolar electrode | 392 999 659 | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 003BC | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 016 | FDA UDI | Class II | Active |
| Laparoscope | 162 053 040 | FDA UDI | Class II | Active |
| Cystoscopy instrument | 395 400 008 | FDA UDI | Class II | Active |
| Grasping forceps | 393 910 274 | FDA UDI | Class II | Active |
| Monopolar electrode | 392 999 915 | FDA UDI | Class II | Active |
| Cystoscopy instrument | 395 400 106 | FDA UDI | Class II | Active |
| Trocar | 191 501 755 | FDA UDI | Class II | Active |
| Veress insufflation needle | 391 127 150 | FDA UDI | Class II | Active |
| Cystoscopy obturator | 198 040 400 | FDA UDI | Class II | Active |
| Cystoscopy instrument | 395 700 020 | FDA UDI | Class II | Active |
| Grasping forceps | 391 305 045 | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 069 | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 109 | FDA UDI | Class II | Active |
| Obturator | 195 900 070BC | FDA UDI | Class II | Active |
| Grasping forceps | 394 920 070 | FDA UDI | Class II | Active |
| Grasping forceps | 394 520 024 | FDA UDI | Class II | Active |
| Monopolar electrode | 392 999 513 | FDA UDI | Class II | Active |
| Cystoscopy instrument | 390 700 400 | FDA UDI | Class II | Active |
| Reducer | 392 998 003 | FDA UDI | Class II | Active |
| Electrode | 395 400 014 C | FDA UDI | Class II | Active |
| Grasping forceps | 393 930 245 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 132 | FDA UDI | Class II | Active |
| Cystoscopy sheath | 198 020 200BC | FDA UDI | Class II | Active |
| Resectoscopy sheath | 195 040 025BC | FDA UDI | Class II | Active |
| Arthroscopy sheath | 191 191 011BC | FDA UDI | Class II | Active |
| Trocar | 191 031 910 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 145 | FDA UDI | Class II | Active |
| Cystoscopy instrument | 398 400 031 | FDA UDI | Class II | Active |
| Suction-irrigation-handle | 191 500 110 | FDA UDI | Class II | Active |
| Laparoscope | 163 312 992BC001 | FDA UDI | Class II | Active |
| Obturator | 195 810 112 | FDA UDI | Class II | Active |
| Laparoscope | 162 053 150BC001 | FDA UDI | Class II | Active |
| Arthroscopy sheath | 191 401 757 | FDA UDI | Class II | Active |
| Trocar sleeve | 191 051 090 | FDA UDI | Class II | Active |
| Grasping forceps | 393 930 205 | FDA UDI | Class II | Active |
| Veress insufflation needle | 391 127 120 | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 170 | FDA UDI | Class II | Active |
| Resectoscopy sheath | 195 810 101BC | FDA UDI | Class II | Active |
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