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Sign in to claim this brandH&abyz Co., Ltd.
US
Last updated May 30, 2026
What H&abyz Co., Ltd. makes
H&abyz Co., Ltd. manufactures indirect flat‑panel X‑ray detectors and portable basic diagnostic digital X‑ray systems. Their product line includes models such as ADD, A1417MCW, A1717MCW, HAD1717MC, HnX‑PB, HnX‑P1, and F1417MCW, among others.
All of these devices are classified as Class II medical devices and are listed in the FDA 510(k) database and the FDA UDI registry. 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 H&abyz Co., Ltd. manufacture?
H&abyz Co., Ltd. produces two main categories of devices: indirect flat‑panel X‑ray detectors and portable basic diagnostic digital X‑ray systems. This conclusion comes directly from the device data, which lists those categories as the most common products the company offers.
Where is H&abyz Co., Ltd. headquartered?
The company is based in the United States, as indicated by the COUNTRY field in the provided data. No other location is mentioned, so the U.S. is the sole listed headquarters.
In which FDA registries are H&abyz’s devices listed?
All of H&abyz’s devices appear in the FDA 510(k) database and the FDA UDI registry. The LISTED IN section of the data explicitly names "fda_510k" and "fda_udi," confirming their presence in both registries.
How are H&abyz’s devices classified under FDA regulations?
Every device from H&abyz is classified as Class II. The DEVICE CLASSES entry states "Class II," and the summary reiterates that all listed models fall under this regulatory class.
Can you give examples of specific models that H&abyz offers?
Yes, the data provides several model names such as ADD, A1417MCW, A1717MCW, HAD1717MC, HnX‑PB, HnX‑P1, and F1417MCW. These examples are directly taken from the EXAMPLE DEVICES list, confirming the range of products they market.
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
- —
- DUNS Number
- 689514436
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Add | HAD1417MCW | FDA UDI | Class II | Active |
| A1417mcw | A1417MCW | FDA UDI | Class II | Active |
| A1717mcw | A1717MCW | FDA UDI | Class II | Active |
| Had1717mc | HAD1717MC | FDA UDI | Class II | Active |
| HnX-PB | HnX-PB | FDA UDI | Class II | Active |
| HnX-P1 | HnX-P1 | FDA UDI | Class II | Active |
| F1417mcw | F1417MCW | FDA UDI | Class II | Active |
| Add | HAD1717MCW | FDA UDI | Class II | Active |
| Add | K203188 | FDA 510(k) | Class II | Active |
| Had1717mc | K200018 | FDA 510(k) | Class II | Active |
| ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | K213497 | FDA 510(k) | Class II | Active |
| A1417mcw/A1717mcw/F1417mcw | K223930 | FDA 510(k) | Class II | Active |
| HnX-P1, HnX-PB | K251223 | FDA 510(k) | Class II | Active |
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