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Sign in to claim this brandWhat Apk Technology makes
Apk Technology manufactures reusable and single-use electrocardiographic lead sets, pulse oximeter probes, pulse co-oximeter probes, and reusable blood pressure cuffs. Their product line also includes reusable electrical-only medical device connection cables, designed for patient monitoring and diagnostic applications.
All devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Apk Technology manufacture?
Apk Technology specializes in reusable and single-use medical devices primarily used for patient monitoring and diagnostics. Their product line includes electrocardiographic lead sets, pulse oximeter probes, pulse co-oximeter probes, and reusable blood pressure cuffs. They also produce reusable electrical-only medical device connection cables, which are designed to facilitate safe and reliable connections between medical equipment and patients.
Where is Apk Technology based?
Apk Technology is based in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under FDA guidelines for medical device compliance.
Which regulatory registries list Apk Technology’s devices?
Apk Technology’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in the healthcare supply chain.
How are Apk Technology’s devices classified under FDA regulations?
All of Apk Technology’s devices fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as monitoring or diagnostic tools.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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- EUDAMED SRN
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- DUNS Number
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Catalogue (1673)
Page 17 of 34| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Apk | A0309-SP202PU | FDA UDI | Class II | Active |
| GE-Nellcor | A1418-SA203PU | FDA UDI | Class II | Active |
| Apk | A3056-EC0 | FDA UDI | Class II | Active |
| Apk | A3049-EC0 | FDA UDI | Class II | Active |
| Nihon Kohden | A1411-SR103PU | FDA UDI | Class II | Active |
| Apk | A0209-SP130PU | FDA UDI | Class II | Active |
| Apk | A5018-EK2L | FDA UDI | Class II | Active |
| Apk | I-TCB-03JA-10AS-0020 | FDA UDI | Class II | Active |
| Apk | A6085-EK2M | FDA UDI | Class II | Active |
| Apk | I-RLW-05BD-MXAS-0000 | FDA UDI | Class II | Active |
| Apk | A3010-EC1BK | FDA UDI | Class II | Active |
| Apk | A1023-SA111PU | FDA UDI | Class II | Active |
| Apk | A1315-SR144MU | FDA UDI | Class II | Active |
| Apk | S810-290 | FDA UDI | Class II | Active |
| Blood pressure cuff | A-XT-09W(8) | FDA UDI | Class II | Active |
| Blood pressure cuff | A-XT-04D(7) | FDA UDI | Class II | Active |
| Apk | A1411-SA03C | FDA UDI | Class II | Active |
| Apk | S810-690 | FDA UDI | Class II | Active |
| Apk | S905-160 | FDA UDI | Class II | Active |
| Apk | S110S-208D0 | FDA UDI | Class II | Active |
| Apk | A1023-SP125PU | FDA UDI | Class II | Active |
| Apk | A5039-EL1 | FDA UDI | Class II | Active |
| Apk | A5095-EL1-002 | FDA UDI | Class II | Active |
| Apk | S910-205D0 | FDA UDI | Class II | Active |
| Apk | A5072-EL2 | FDA UDI | Class II | Active |
| Apk | S503-070 | FDA UDI | Class II | Active |
| Apk | I-DLP-05BM-40AM-0100 | FDA UDI | Class II | Active |
| Apk | A0410-EZ4 | FDA UDI | Class II | Active |
| Apk | A0309-SW102PU | FDA UDI | Class II | Active |
| Apk | S410-205D0 | FDA UDI | Class II | Active |
| Apk | A1315-SN09M | FDA UDI | Class II | Active |
| Apk | I-RLW-05AM-29V5-0000 | FDA UDI | Class II | Active |
| Apk | A0816-SA206PU | FDA UDI | Class II | Active |
| Apk | I-RLW-05AW-29AS-0000 | FDA UDI | Class II | Active |
| Apk | S910-1210 | FDA UDI | Class II | Active |
| Apk | A5078-EK2E | FDA UDI | Class II | Active |
| Apk | I-DLP-05BV-40AS-0100 | FDA UDI | Class II | Active |
| Apk | A0509-SW111PU | FDA UDI | Class II | Active |
| Apk | I-RLW-05BC-40RA-0000 | FDA UDI | Class II | Active |
| Apk | I-LDW-05AB-51AS-0100 | FDA UDI | Class II | Active |
| Apk | A1414-SW203PU | FDA UDI | Class II | Active |
| Apk | A5067-EL0 | FDA UDI | Class II | Active |
| Nihon Kohden | A1411-SW136PU | FDA UDI | Class II | Active |
| Apk | A6096-EL1 | FDA UDI | Class II | Active |
| Apk | A5010-EC0PH | FDA UDI | Class II | Active |
| Apk | A1411-SP09 | FDA UDI | Class II | Active |
| Apk | I-TCB-05MA-10AS-0030 | FDA UDI | Class II | Active |
| Apk | A3078-EC1 | FDA UDI | Class II | Active |
| Apk | A0212-SA149MV | FDA UDI | Class II | Active |
| Blood pressure cuff | A-XT-02D(10) | FDA UDI | Class II | Active |
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