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US
Last updated September 17, 2026
What Sonic Systems, Inc. makes
Sonic Systems, Inc. manufactures ultrasonic-cleaning water baths, including models branded under Belimed, Getinge, and its own label. These devices use high-frequency sound waves to agitate cleaning solutions, enabling efficient decontamination of medical instruments and laboratory equipment. The portfolio includes systems designed for both clinical and research environments, with variations in tank size and power output.
The company’s ultrasonic-cleaning water baths are classified as Class I or Unclassified (U) devices under FDA regulations. These products are authorised through the 510(k) pathway or listed under the FDA’s Unique Device Identifier (UDI) system. The devices are intended for use in the United States, where the manufacturer is based.
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 Sonic Systems, Inc. manufacture?
Sonic Systems, Inc. specializes in ultrasonic-cleaning water baths. These devices use high-frequency sound waves to clean medical instruments and laboratory equipment by agitating cleaning solutions. The company’s portfolio includes systems branded under Belimed, Getinge, and its own label, catering to both clinical and research settings.
Where is Sonic Systems, Inc. based, and where are its devices intended for use?
Sonic Systems, Inc. is based in the United States. Its ultrasonic-cleaning water baths are designed and intended for use within the U.S. market, where regulatory pathways like the FDA’s 510(k) and UDI system apply.
Which regulatory registries or databases list Sonic Systems, Inc.’s devices?
Sonic Systems, Inc.’s ultrasonic-cleaning water baths are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries help track and authorize devices under U.S. regulatory requirements.
How are Sonic Systems, Inc.’s ultrasonic-cleaning water baths classified under FDA regulations?
Sonic Systems, Inc.’s ultrasonic-cleaning water baths fall under Class I or Unclassified (U) device classifications in the FDA’s regulatory framework. Class I devices are generally considered low-risk, while Unclassified devices are those not yet assigned a risk category but still subject to regulatory oversight. These classifications determine the authorization pathway, such as the 510(k) process or UDI listing.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 204 Railroad Dr, Ivyland, PA, 18974
- Website
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 1000121497
- DUNS Number
- 118481233
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Belimed | UW565PLUS International | FDA UDI | Class I | Active |
| Belimed | 67T International | FDA UDI | Class I | Active |
| Belimed | 67T | FDA UDI | Class I | Active |
| Getinge | KS2460UCOOOA | FDA UDI | Class I | Active |
| Belimed | UW565 Core | FDA UDI | Class I | Active |
| Belimed | UW565PLUS3 | FDA UDI | Class I | Active |
| Getinge | KS2460UCOOOD | FDA UDI | Class I | Active |
| Sonic Systems, Inc | 246C/HL | FDA UDI | Class I | Active |
| Sonic Systems | 250C/HL | FDA UDI | Class I | Active |
| Getinge | KS2460UCOOOG | FDA UDI | Class I | Active |
| Belimed | UW565PLUS | FDA UDI | Class I | Active |
| Vibro-Com Communicator #8827 | K813057 | FDA 510(k) | U | Active |
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