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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 3 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hook | 391 305 035 | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 135 | FDA UDI | Class II | Active |
| Grasping forceps | 393 930 274 | FDA UDI | Class II | Active |
| Biopsy forceps | 393 510 106 | FDA UDI | Class II | Active |
| Grasping forceps | 393 920 135 | FDA UDI | Class II | Active |
| Cystoscope | 165 271 875 | FDA UDI | Class II | Active |
| Scissors | 393 560 150 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 020 | FDA UDI | Class II | Active |
| Arthroscopy sheath | 191 402 294BC | FDA UDI | Class II | Active |
| Trocar | 191 051 950 | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 114 | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 118 | FDA UDI | Class II | Active |
| Grasping forceps | 393 930 031 | FDA UDI | Class II | Active |
| Arthroscopy hand instruments | 391 410 008 | FDA UDI | Class II | Active |
| Biopsy forceps | 393 520 007 | FDA UDI | Class II | Active |
| Trocar | 191 271 755BC | FDA UDI | Class II | Active |
| Veress insufflation needle | 391 027 100 | FDA UDI | Class II | Active |
| Cystoscopy instrument | 395 400 004 | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 008BC | FDA UDI | Class II | Active |
| Reducer | 392 999 003 | FDA UDI | Class II | Active |
| Cystoscope | 165 303 002 | FDA UDI | Class II | Active |
| Dissecting forceps | 393 510 034 | FDA UDI | Class II | Active |
| Urology syringe | 199 090 200 | FDA UDI | Class II | Active |
| Electrode | 195 100 000 | FDA UDI | Class II | Active |
| Stone basket | 395 400 100 | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 005 | FDA UDI | Class II | Active |
| Punch | 391 305 011 | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 012 | FDA UDI | Class II | Active |
| Suction irrigation sheath | 191 401 770 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 035 | FDA UDI | Class II | Active |
| Obturator | 191 501 756BC | FDA UDI | Class II | Active |
| Resectoscopy sheath | 199 075 020BC | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 001BC | FDA UDI | Class II | Active |
| Punch | 391 352 113 | FDA UDI | Class II | Active |
| Resectoscopy working element | 195 020 000BC | FDA UDI | Class II | Active |
| Grasping forceps | 394 510 076 | FDA UDI | Class II | Active |
| Cystoscopy obturator | 196 040 400BC | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 179 | FDA UDI | Class II | Active |
| Urethrotomy sheath | 199 110 050 | FDA UDI | Class II | Active |
| Scissors | 391 350 000 | FDA UDI | Class II | Active |
| Monopolar electrode | 392 999 512 | FDA UDI | Class II | Active |
| Grasping forceps | 394 510 070 | FDA UDI | Class II | Active |
| Electrode | 195 810 120 C | FDA UDI | Class II | Active |
| Grasping forceps | 394 510 010 | FDA UDI | Class II | Active |
| Suction-irrigation-tube | 191 400 105BC | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 036 | FDA UDI | Class II | Active |
| Trocar | 195 200 210 | FDA UDI | Class II | Active |
| Cystoscopy obturator | 198 040 200 | FDA UDI | Class II | Active |
| Hysteroscopy sheath | 191 293 052BC | FDA UDI | Class II | Active |
| Cystoscopy instrument | 395 400 105 | FDA UDI | Class II | Active |
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