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Sign in to claim this brandW.O.M. World of Medicine GmbH
US
Last updated May 23, 2026
What W.O.M. World of Medicine GmbH makes
W.O.M. World of Medicine GmbH manufactures single-use and reusable devices for laparoscopic and endoscopic procedures, including insufflation systems like the Synergy Insufflation and GYN-Pump, as well as irrigation tubing sets and endoscopic camera systems. Their portfolio also covers specialized components such as CO₂ gas hoses for surgical applications, foot pedals for control, and a Xenon light source for illumination. Nuclear medicine tools, like the hand-held detector system, and fluid control solutions, including the Aquilex® Fluid Control System, are also part of their offerings.
The company’s devices are regulated under FDA pathways, including 510(k) clearances and De Novo authorizations, with products classified primarily as Class I and Class II. These devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The manufacturer operates from the United States.
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 W.O.M. World of Medicine GmbH primarily manufacture?
W.O.M. World of Medicine GmbH specializes in devices for laparoscopic and endoscopic procedures. Their portfolio includes single-use and reusable items like insufflation systems (such as the Synergy Insufflation and GYN-Pump), irrigation tubing sets, endoscopic camera systems, and specialized components like CO₂ gas hoses. They also produce nuclear medicine tools, such as a hand-held detector system, and fluid control solutions like the Aquilex® Fluid Control System. These devices support surgical insufflation, irrigation, illumination, and fluid management in various medical settings.
Where is W.O.M. World of Medicine GmbH based, and how does that affect its regulatory oversight?
W.O.M. World of Medicine GmbH is based in the United States. As a U.S.-based manufacturer, its devices fall under FDA regulatory jurisdiction. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, indicating they undergo FDA review pathways such as 510(k) clearances or De Novo authorizations. The U.S. location ensures compliance with FDA standards for medical device safety and performance.
Which regulatory registries list W.O.M. World of Medicine GmbH’s devices, and why is this important?
W.O.M. World of Medicine GmbH’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. Inclusion in these registries confirms that the devices have undergone FDA review and meet regulatory requirements for market authorization. The 510(k) pathway demonstrates that the devices are substantially equivalent to legally marketed predicates, while UDI registration ensures traceability and transparency in the supply chain, which is critical for healthcare providers and regulatory compliance.
How are W.O.M. World of Medicine GmbH’s devices classified under FDA regulations, and what does this classification mean?
W.O.M. World of Medicine GmbH’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, such as registration and listing requirements. Class II devices involve a higher risk and require premarket notification (510(k)) to ensure safety and effectiveness. The classification reflects the intended use and potential risk of the device, guiding the regulatory pathway and oversight level required by the FDA.
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
- 316305242
Catalogue (197)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NIST Adapter for universal gas connection | 0620050912 | FDA UDI | Class I | Active |
| Xenon Light Source | XL300 | FDA UDI | Class II | Active |
| Synergy Insufflation | FM134 | FDA UDI | Class II | Active |
| Aquilex® Fluid Control System | AQL-100P | FDA UDI | Class II | Active |
| GYN-Pump | PH304 | FDA UDI | Class II | Active |
| Foot pedal | Z0106-01 | FDA UDI | Class II | Active |
| Hose for CO2 central gas DISS:DISS, 3m | INSFCDISS3 | FDA UDI | Class I | Active |
| Hose for CO2 central gas supply DIN:US, 5 m | Z5101-01 | FDA UDI | Class I | Active |
| Endoscopic camera | HDC907/HDC407 | FDA UDI | Class II | Active |
| Foot Pedal | Z0301-01 | FDA UDI | Class II | Active |
| GoFlo Pump | A127 | FDA UDI | Class II | Active |
| Hose for CO2 central gas UNI:US, 5m | INSFCHSEUNI | FDA UDI | Class I | Active |
| Hose for CO2 central gas NF:US, 5m | INSFCHSENF | FDA UDI | Class I | Active |
| Hose for CO2 central gas supply NF-US, 3 m | 0620050908 | FDA UDI | Class I | Active |
| InsufflationTube Set / ISO / Disposable | AR-3290-1001 | FDA UDI | Class II | Active |
| Endoscopic camera | HDC907 | FDA UDI | Class II | Active |
| Hose for CO2 gas bottle DIN:US, 1.5m | Z5044-01 | FDA UDI | Class I | Active |
| High pressure tube CO2 DIN:US | iFS-HPH2 | FDA UDI | Class I | Active |
| Hose for CO2 central gas AGA:US, 5m | Z5107-01 | FDA UDI | Class I | Active |
| DISS Adapter for universal gas connection | INSFDISSADP | FDA UDI | Class I | Active |
| High pressure tube CO2 ISO:US | iFS-HPH3 | FDA UDI | Class I | Active |
| Pump tube, single use | 4170.226 | FDA UDI | Class II | Active |
| Tube set for insufflation, single-use | Z1422-01 | FDA UDI | Class II | Active |
| Heating tube set for insufflation, single use | Z0260 | FDA UDI | Class II | Active |
| HysteroLux™ Fluid Management System Control Unit | PH304 | FDA UDI | Class II | Active |
| Tube set for suction, single-use | 4170.901 | FDA UDI | Class II | Active |
| Heating tube set for insufflation, single use | Z0260 | FDA UDI | Class II | Active |
| Hose for CO2 gas bottle DIN:US, 1.5m | Z5044-01 | FDA UDI | Class I | Active |
| Insufflator | F104 | FDA UDI | Class II | Active |
| Fluid Monitoring Unit | PS304 | FDA UDI | Class II | Active |
| Hose for CO2 central gas supply NF:US, 3 m | Z5102-01 | FDA UDI | Class I | Active |
| Hose for CO2 central gas DIN:US, 5m | Z5101-01 | FDA UDI | Class I | Active |
| Tube set for suction (with 2 ports), single-use | OTFLWTBING | FDA UDI | Class II | Active |
| Full HD-Camera | HDC1600 | FDA UDI | Class II | Active |
| Foot pedal | IFFTSWITCH | FDA UDI | Class II | Active |
| Insufflator for Laparoscopy | F102 | FDA UDI | Class II | Active |
| Fluid Monitoring Unit | PS304 | FDA UDI | Class II | Active |
| Smoke Evacuation High-Flow Tube Set | 0620050250 | FDA UDI | Class II | Active |
| Endoscopic camera | HDC907 | FDA UDI | Class II | Active |
| Aquilex Fluid Control System | AQL-100PBS | FDA UDI | Class II | Active |
| Tube set for suction, single-use | AQL-111 | FDA UDI | Class II | Active |
| Hose for CO2 central gas supply UNI:US, 5 m | Z5105-01 | FDA UDI | Class I | Active |
| Vacuum Protection Gas Filter, hydrophobic | Z0556-01 | FDA UDI | Class II | Active |
| CO2 gas connecter, straight | Z5078-01 | FDA UDI | Class I | Active |
| Endoscopic camera | HDCam 1080p | FDA UDI | Class II | Active |
| Tube set for suction, single-use | Z1406-01 | FDA UDI | Class II | Active |
| Gamma Finder® Iii | GAMMA FINDER® III | FDA UDI | Class I | Active |
| Gas connector US angled | Z5070-01 | FDA UDI | Class I | Active |
| Aquilex® Fluid Control System | AQL-100CS | FDA UDI | Class II | Active |
| Hose for CO2 central gas supply UNI-US, 5 m | 0620050911 | FDA UDI | Class I | Active |
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