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Sign in to claim this brandAscom Sweden AB
US
Last updated May 23, 2026
What Ascom Sweden AB makes
Ascom Sweden AB manufactures nurse call systems and alarm application software, providing integrated communication solutions for healthcare facilities.
These products are classified as Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries; the company is based in 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 Ascom Sweden AB manufacture?
Ascom Sweden AB produces nurse call systems and alarm application software, which are integrated communication solutions for healthcare facilities. This is derived directly from the device categories listed in the provided data, indicating these are the primary products the company offers.
Where is Ascom Sweden AB based and how does that relate to its regulatory listings?
The data states that Ascom Sweden AB is based in the United States. Because it operates in the US, its devices are listed in the FDA 510(k) and FDA UDI registries, which are the primary US regulatory databases for medical devices.
In which FDA registries are Ascom Sweden AB's devices listed?
According to the information, the company's devices appear in both the FDA 510(k) and FDA UDI registries. These listings indicate that each device has undergone the FDA's premarket notification process and has a unique device identifier, as required for Class II devices.
How are Ascom Sweden AB's devices classified under FDA regulations?
The device classes specified are Class II. This classification is based on the risk level and regulatory controls required for nurse call systems and alarm application software, as explicitly noted in the provided device class information.
Why are Ascom Sweden AB's nurse call systems considered Class II devices?
Class II classification reflects moderate risk and the need for special controls, which is appropriate for communication and alarm systems used in patient care. The data directly assigns Class II to the company's products, indicating they meet these regulatory criteria.
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
- 356107490
Catalogue (82)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ascom | HC-CCPSTN-3K | FDA UDI | Class II | Active |
| Ascom | Cardiomax | FDA UDI | Class II | Active |
| Ascom | NUHS3B6-H | FDA UDI | Class II | Active |
| Ascom | Unite View | FDA UDI | Class II | Active |
| Ascom | HC-PSTN1-BED | FDA UDI | Class II | Active |
| Ascom | HC-CL1-RED | FDA UDI | Class II | Active |
| Ascom | HC-CL2-3K | FDA UDI | Class II | Active |
| Ascom | NULAPC3-HU | FDA UDI | Class II | Active |
| Ascom | NUPBC-H | FDA UDI | Class II | Active |
| Ascom | HC-VSTN | FDA UDI | Class II | Active |
| Ascom | NGTELL51-S | FDA UDI | Class II | Unknown |
| Ascom | HC-CCSTN-3K | FDA UDI | Class II | Active |
| Ascom | NGWDSP-H | FDA UDI | Class II | Active |
| Ascom | NURGW-H | FDA UDI | Class II | Active |
| Ascom | NGTELL70-S | FDA UDI | Class II | Active |
| Ascom | Unite Connect for Nurse Call | FDA UDI | Class II | Active |
| Ascom | HC-PAGE | FDA UDI | Class II | Active |
| Ascom | NGTELL68-S | FDA UDI | Class II | Active |
| Ascom | HC-IPSWITCH8 | FDA UDI | Class II | Active |
| Ascom | HC-BID-SS37 | FDA UDI | Class II | Active |
| Ascom | NUBR37-HU | FDA UDI | Class II | Active |
| Ascom | HC-PSTN2-3K | FDA UDI | Class II | Active |
| Ascom | NUHS7B-H | FDA UDI | Class II | Active |
| Ascom | HC-PP2-LAV-3K | FDA UDI | Class II | Active |
| Ascom | HC-PSTN1-3K | FDA UDI | Class II | Active |
| Ascom | NGTELL610-S | FDA UDI | Class II | Active |
| Ascom | NGTELL52-S | FDA UDI | Class II | Active |
| Ascom | NUCL4-H | FDA UDI | Class II | Active |
| Ascom | NGTELL65-S | FDA UDI | Class II | Active |
| Ascom | NGTELL64-S | FDA UDI | Class II | Active |
| Unite Connect for Clinical Systems | K180566 | FDA 510(k) | Class II | Active |
| Ascom Mobile Monitoring Gateway (mmg) | K111215 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Ascom Sweden Ab Goteborg Vastra Gotaland · SE FEI 3008952681