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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 1 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bronchoscope | 164 055 000BC001 | FDA UDI | Class II | Active |
| Grasping forceps | 393 910 272 | FDA UDI | Class II | Active |
| Arthroscopy sheath | 191 240 933BC | FDA UDI | Class II | Active |
| Urology syringe | 195 090 200 | FDA UDI | Class II | Active |
| Cystoscope | 161 271 140 | FDA UDI | Class II | Active |
| Veress insufflation needle | 391 020 060 | FDA UDI | Class II | Active |
| Grasping forceps | 394 510 024 | FDA UDI | Class II | Active |
| Grasping forceps | 393 320 101 | FDA UDI | Class II | Active |
| Scissors | 393 100 200 | FDA UDI | Class II | Active |
| Grasping forceps | 394 520 073 | FDA UDI | Class II | Active |
| Bipolar forceps | 392 993 118 | FDA UDI | Class II | Active |
| Grasping forceps | 393 910 135 | FDA UDI | Class II | Active |
| Trocar | 191 501 755BC | FDA UDI | Class II | Active |
| Sinuscope | 161 271 780 | FDA UDI | Class II | Active |
| Grasping forceps | 393 930 273 | FDA UDI | Class II | Active |
| Trocar sleeve | 191 111 110 | FDA UDI | Class II | Active |
| Grasping forceps | 393 530 171 | FDA UDI | Class II | Active |
| Obturator | 191 401 756BC | FDA UDI | Class II | Active |
| Arthroscope Bridge | 191 401 781 | FDA UDI | Class II | Active |
| Cystoscopy adaptor | 196 050 200BC | FDA UDI | Class II | Active |
| Trocar | 191 271 755 | FDA UDI | Class II | Active |
| Trocar | 191 051 910 | FDA UDI | Class II | Active |
| Cystoscopy sheath | 196 080 200 | FDA UDI | Class II | Active |
| Laparoscope | 162 103 252BC001 | FDA UDI | Class II | Active |
| Urethrotomy knife | 195 810 122BC | FDA UDI | Class II | Active |
| Suction irrigation sheath | 191 401 771 | FDA UDI | Class II | Active |
| Sinuscope | 161 271 762 | FDA UDI | Class II | Active |
| Obturator | 191 501 766BC | FDA UDI | Class II | Active |
| Electrode | 195 100 052 C | FDA UDI | Class II | Active |
| Cystoscopy sheath | 198 020 500 | FDA UDI | Class II | Active |
| Monopolar HF cable | 395 502 507 | FDA UDI | Class II | Active |
| Grasping forceps | 394 520 011 | FDA UDI | Class II | Active |
| Electrode | 395 400 048 C | FDA UDI | Class II | Active |
| Trocar | 195 200 200 | FDA UDI | Class II | Active |
| Knot guide | 392 999 453 | FDA UDI | Class II | Active |
| Hysteroscopy sheath | 191 293 052 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 136 | FDA UDI | Class II | Active |
| Accessory for urology | 395 410 012BC | FDA UDI | Class II | Active |
| Bipolar forceps | 392 993 024 | FDA UDI | Class II | Active |
| Obturator | 191 402 256BC | FDA UDI | Class II | Active |
| Resectoscopy working element | 199 010 020 | FDA UDI | Class II | Active |
| Grasping forceps | 394 520 037 | FDA UDI | Class II | Active |
| Sinuscope | 161 271 762BC001 | FDA UDI | Class II | Active |
| Working element | 196 010 010 | FDA UDI | Class II | Active |
| Cystoscope | 165 271 872BC001 | FDA UDI | Class II | Active |
| Grasping forceps | 393 930 078 | FDA UDI | Class II | Active |
| Sinuscope | 161 401 802BC001 | FDA UDI | Class II | Active |
| Laparoscope | 162 053 152BC001 | FDA UDI | Class II | Active |
| Grasping forceps | 393 520 177 | FDA UDI | Class II | Active |
| Grasping forceps | 393 510 169 | FDA UDI | Class II | Active |
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