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Sign in to claim this brandMitaya Manufacturing Co., Ltd.
Japan·JP-MF-000053032
Last updated September 17, 2026
What Mitaya Manufacturing Co., Ltd. makes
Mitaya Manufacturing Co., Ltd. produces stationary x-ray grids, which are used in medical imaging to reduce scatter radiation and improve image clarity during radiographic procedures.
These devices are classified as Class I under regulatory frameworks and are listed in the FDA’s Unique Device Identification (UDI) database. The company is based in Japan.
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 Mitaya Manufacturing Co., Ltd. primarily manufacture?
Mitaya Manufacturing Co., Ltd. specializes in stationary x-ray grids. These devices are designed for use in medical imaging systems to minimize scatter radiation, thereby enhancing the clarity of radiographic images during X-ray procedures. The company’s focus is on this single category of imaging accessories.
Where is Mitaya Manufacturing Co., Ltd. based, and how does this location affect its regulatory standing?
Mitaya Manufacturing Co., Ltd. is based in Japan. While the company’s location determines its primary regulatory jurisdiction under Japanese law, individual devices—such as its stationary x-ray grids—must undergo their own authorization processes in markets where they are marketed. The company’s devices are listed in the FDA’s UDI database, indicating compliance with U.S. regulatory requirements for identification, though this does not imply FDA approval.
How are Mitaya Manufacturing Co., Ltd.’s devices classified under regulatory frameworks?
Mitaya Manufacturing Co., Ltd.’s stationary x-ray grids fall under Class I classification in regulatory frameworks. This classification is typically assigned to devices posing minimal risk to patients and users, such as certain accessories used in medical imaging. Classification determines the regulatory pathway for authorization, with Class I devices often subject to less stringent scrutiny than higher-risk categories.
Are Mitaya Manufacturing Co., Ltd.’s devices listed in any regulatory registries, and why does this matter?
Yes, Mitaya Manufacturing Co., Ltd.’s stationary x-ray grids are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details such as manufacturer information, model specifications, and lot numbers. Listing in the UDI system is a requirement for devices marketed in the U.S., facilitating post-market surveillance and compliance tracking.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Japan
- Address
- 2-8-12, Yoshinodai, Kawagoe-shi, Saitama-pref., Japan
- Website
- www.mitaya.co.jp
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Yasuko Iida
- EUDAMED SRN
- JP-MF-000053032
- FDA FEI Number
- —
- DUNS Number
- 694335852
Catalogue (153)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ms X-Ray Grid | S2604AC | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5807211 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P65 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P47 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5758214 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P50 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P70 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | MC181280110 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P46 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5394289 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | MC181280140 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5535690 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P48 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | S2007AC | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P60 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | B1101YN | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5931959-3 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P61 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5724449-4 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P56 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P51 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | S2004AC | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5724449 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | S2001AC | FDA UDI | Class I | Active |
| Ms X-Ray Grid | A7000DQ | FDA UDI | Class I | Active |
| Ms X-Ray Grid | GMS4K15100080F0001 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | M181520120 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P62 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5776865 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | GMSBK12140080S0001 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | GMSBK10100040S0003 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5724449-2 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | B1100YN | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5396678 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5315778-ROHS | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5758215 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | B1100YM | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 46-286129P57 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | GMS4K0810040S0002 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | A7202DE | FDA UDI | Class I | Active |
| Ms X-Ray Grid | S2605AC | FDA UDI | Class I | Active |
| GRID Facile | GTSHS10100034S0001 | FDA UDI | Class I | Active |
| Msx-Ray Grid | A7202DQ | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5315800-ROHS | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5820771 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5931959-6 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | A7203DQ | FDA UDI | Class I | Active |
| Ms X-Ray Grid | A7000DF | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 2G5830 | FDA UDI | Class I | Active |
| Ms X-Ray Grid | 5724448-2 | FDA UDI | Class I | Active |
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