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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 4 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hysteroscopy obturator | 191 273 046 | FDA UDI | Class II | Active |
| Resectoscopy working element | 199 020 000 | FDA UDI | Class II | Active |
| Bipolar forceps | 392 993 021 | FDA UDI | Class II | Active |
| Scissors | 394 560 003 | FDA UDI | Class II | Active |
| Dilation set | 191 402 257 | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 143 | FDA UDI | Class II | Active |
| Grasping forceps | 391 305 020 | FDA UDI | Class II | Active |
| Laparoscope | 162 102 740 | FDA UDI | Class II | Active |
| Monopolar HF cable | 395 502 502 | FDA UDI | Class II | Active |
| Electrode | 195 800 120 | FDA UDI | Class II | Active |
| Monopolar HF cable | 395 502 508 | FDA UDI | Class II | Active |
| Scissors | 391 350 023 | FDA UDI | Class II | Active |
| Biopsy forceps | 393 510 015 | FDA UDI | Class II | Active |
| Monopolar electrode | 392 999 614 | FDA UDI | Class II | Active |
| Grasping forceps | 393 320 118 | FDA UDI | Class II | Active |
| Scissors | 393 960 202 | FDA UDI | Class II | Active |
| Arthroscope | 161 271 192 | FDA UDI | Class II | Active |
| Electrode | 195 100 001 | FDA UDI | Class II | Active |
| Grasping forceps | 393 930 242 | FDA UDI | Class II | Active |
| Resectoscopy working element | 195 020 040 | FDA UDI | Class II | Active |
| Cystoscopy adaptor | 196 800 150 | FDA UDI | Class II | Active |
| Cystoscopy sheath | 196 020 300BC | FDA UDI | Class II | Active |
| Grasping forceps | 393 910 138 | FDA UDI | Class II | Active |
| Grasping forceps | 391 354 250 | FDA UDI | Class II | Active |
| Monopolar electrode | 392 999 914 | FDA UDI | Class II | Active |
| Grasping forceps | 393 910 278 | FDA UDI | Class II | Active |
| Trocar | 191 051 960 | FDA UDI | Class II | Active |
| Laparoscope | 162 054 500BC001 | FDA UDI | Class II | Active |
| Sinuscope | 161 401 813BC001 | FDA UDI | Class II | Active |
| Cystoscopy sheath | 196 800 100BC | FDA UDI | Class II | Active |
| Reducer | 392 999 006 | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 018 | FDA UDI | Class II | Active |
| Obturator | 195 050 002 | FDA UDI | Class II | Active |
| Hook | 391 305 040 | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 128 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 119 | FDA UDI | Class II | Active |
| Dissecting forceps | 394 530 034 | FDA UDI | Class II | Active |
| Resectoscopy sheath | 199 040 514BC | FDA UDI | Class II | Active |
| Laparoscope | 162 053 153 | FDA UDI | Class II | Active |
| Suction-irrigation-tube | 191 400 105 | FDA UDI | Class II | Active |
| Hysteroscopy obturator | 191 203 046BC | FDA UDI | Class II | Active |
| Punch | 397 100 224 | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 017 | FDA UDI | Class II | Active |
| Bipolar dissector | 392 993 123 | FDA UDI | Class II | Active |
| Hysteroscopy sheath | 191 403 100BC | FDA UDI | Class II | Active |
| Cystoscopy obturator | 198 070 500BC | FDA UDI | Class II | Active |
| Obturator | 199 060 000BC | FDA UDI | Class II | Active |
| Hysteroscopy sheath | 191 273 050BC | FDA UDI | Class II | Active |
| Grasping forceps | 394 520 008 | FDA UDI | Class II | Active |
| Knot guide | 392 999 450 | FDA UDI | Class II | Active |
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