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Sign in to claim this brandAnacom Medtek
US
Last updated May 23, 2026
What Anacom Medtek makes
Anacom Medtek manufactures pillow speakers designed for medical environments, including models from the Series 7 and Series 8 lines. These devices integrate audio functionality into patient pillows, enabling hands-free communication and entertainment for users.
The company’s products fall under FDA Class II regulation and are listed in the FDA’s Unique Device Identifier (UDI) database. Anacom Medtek 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 Anacom Medtek manufacture?
Anacom Medtek specializes in pillow speakers designed for medical environments. These devices are integrated into patient pillows and provide hands-free audio functionality, allowing users to communicate or access entertainment without needing to hold or interact with separate equipment. The focus is on enhancing patient comfort and convenience in healthcare settings.
Where is Anacom Medtek based?
Anacom Medtek is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries list Anacom Medtek’s devices?
Anacom Medtek’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II medical devices, including the pillow speakers from their Series 7 and Series 8 lines. Listing in the UDI database is a requirement for FDA-regulated devices to facilitate tracking and compliance.
How are Anacom Medtek’s devices classified by regulatory authorities?
Anacom Medtek’s devices fall under FDA Class II classification. This classification is assigned based on the risk level of the device—Class II devices generally pose moderate risks and require special controls in addition to general controls to ensure safety and effectiveness. Pillow speakers, like those from the Series 7 and Series 8 lines, are categorized this way due to their intended use in medical environments where functionality and reliability are critical.
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
- 047785845
Catalogue (809)
Page 16 of 17| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Series 8 Anacom MedTek | A3217-088DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A8101-087.1D | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B3516-127.1 | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B0816-157.1D | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A1501-087.1D | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A5389-087.1 | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A4813-087.1D | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B3516-127.1D | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A1869-088DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B2603-087.1 | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A4030-088DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | B0732-00.58DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A1612-087.1 | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B3515-087.1 | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A4031-088DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | B3516-088DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A1589-087.1J | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B0816-127.1D | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A8159-088DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B0822-087.1 | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A2919-088DJM | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A5351-008DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | B5200-088DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A4200-088DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A1491-088DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A1587-127.1JU | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | B0878-088DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A9722-088DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A2937-088DJM | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A1804-087.1D | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A1816-087.1D | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | B0921-088DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A2901-088JM | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | B0854-088DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B3426-087.1DJUM | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A6833-087.1D | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A5314-087.1 | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A4024-088DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A1804-128DLJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | B3472-128DJM | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A5908-088DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B0810-087.1 | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A1501-087.1J | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | A1841-087.1J | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B5212-087.1 | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A1905-088DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B3506-087.1J | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | A4027-088DJ | FDA UDI | Class II | Active |
| Series 8 Anacom MedTek | B2303-088DJ | FDA UDI | Class II | Active |
| Series 7 Anacom MedTek | B0912-127.1J | FDA UDI | Class II | Active |
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