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Sign in to claim this brandDR.JAPAN CO., LTD.
US
Last updated May 24, 2026
What DR.JAPAN CO., LTD. makes
DR.JAPAN Co., Ltd. manufactures single-use spinal needles and non-threaded epidural needles, designed for medical procedures requiring precise insertion into spinal or epidural spaces.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The company is based in the US.
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 DR.JAPAN Co., Ltd. manufacture?
DR.JAPAN Co., Ltd. specializes in single-use medical needles designed for spinal and epidural procedures. Specifically, they produce spinal needles and non-threaded epidural needles, which are used for precise insertion into spinal or epidural spaces during medical interventions.
Where is DR.JAPAN Co., Ltd. based?
DR.JAPAN Co., Ltd. is headquartered in the United States. The company’s location is relevant for understanding its regulatory and operational context, particularly in relation to FDA compliance and reporting requirements.
How are the devices manufactured by DR.JAPAN Co., Ltd. classified under FDA regulations?
The devices produced by DR.JAPAN Co., Ltd., including their spinal and epidural needles, are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Which regulatory registries list the devices made by DR.JAPAN Co., Ltd.?
The devices manufactured by DR.JAPAN Co., Ltd. are included in the FDA’s 510(k) premarket notification program registry and the FDA’s Unique Device Identifier (UDI) system. These registries help track device performance, compliance, and post-market reporting to ensure patient safety and regulatory transparency.
Why are the devices from DR.JAPAN Co., Ltd. listed in the FDA’s UDI system?
The devices from DR.JAPAN Co., Ltd. are listed in the FDA’s UDI system to enable standardized identification across healthcare settings. UDIs improve tracking, reduce medical errors, and facilitate better inventory management and post-market surveillance. This system ensures that each device can be uniquely identified throughout its lifecycle, from manufacturing to patient use.
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
- 701082349
Catalogue (129)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Phoenix | CHE22G100 | FDA UDI | Class II | Active |
| Phoenix | TUFW18G350 | FDA UDI | Class II | Active |
| Phoenix | SN25G500 | FDA UDI | Class II | Active |
| Phoenix | TU18G250 | FDA UDI | Class II | Active |
| Phoenix | TU22G250 | FDA UDI | Class II | Active |
| Phoenix | SN25G800 | FDA UDI | Class II | Active |
| Phoenix | PP27G350 | FDA UDI | Class II | Active |
| Phoenix | SN23G200 | FDA UDI | Class II | Active |
| Phoenix | SNME22G350 | FDA UDI | Class II | Active |
| Phoenix | SN25G350 | FDA UDI | Class II | Active |
| Phoenix | HU20G350 | FDA UDI | Class II | Active |
| Phoenix | SN25G250 | FDA UDI | Class II | Active |
| Phoenix | WES20G350 | FDA UDI | Class II | Active |
| Phoenix | SN22G700-RW | FDA UDI | Class II | Active |
| Phoenix | WVC16G350 | FDA UDI | Class II | Active |
| Phoenix | NE553 | FDA UDI | Class II | Active |
| Phoenix | SN18G300 | FDA UDI | Class II | Active |
| Phoenix | SN23G200 | FDA UDI | Class II | Active |
| Phoenix | SN25G150 | FDA UDI | Class II | Active |
| Phoenix | SN23G500 | FDA UDI | Class II | Active |
| Phoenix | SN22G150-RW | FDA UDI | Class II | Active |
| Phoenix | SN25G150 | FDA UDI | Class II | Active |
| Phoenix | PP2225G500-INT | FDA UDI | Class II | Active |
| Phoenix | SN22G600-RW | FDA UDI | Class II | Active |
| Phoenix | SN22G250-RW | FDA UDI | Class II | Active |
| Phoenix | CHE18G800 | FDA UDI | Class II | Active |
| Phoenix | SN22G500-SB | FDA UDI | Class II | Active |
| Phoenix | CHE22G700 | FDA UDI | Class II | Active |
| Dr J Spinal and Epidural Needles | K183316 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dr. Japan Co., Ltd. Gyoda City Saitama · JP FEI 3009384766