Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAMTEC CO., LTD.
Japan·JP-MF-000001277
Last updated September 18, 2026
About
AMTEC is a pioneer in cleaning agents for hemodialysis machine. It's time to take things to the next level with our medical expertise.
From the manufacturer's own website. Source
What AMTEC CO., LTD. makes
AMTEC Co., Ltd. makes cleaning agents for hemodialysis machines, including products such as Citrix-LA, NClean-CA30, Citrix-50H, Sanacide, NClean-CA20, and NClean-PAA.
These devices are classified as Class IIb and are listed in the Eudamed registry; 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 does AMTEC Co., Ltd. make?
AMTEC Co., Ltd. makes cleaning agents for hemodialysis machines, including products such as Citrix-LA, NClean-CA30, Citrix-50H, Sanacide, NClean-CA20, and NClean-PAA. These are medical devices designed for use in dialysis equipment maintenance.
Where is AMTEC Co., Ltd. based?
AMTEC Co., Ltd. is based in Japan, as indicated by the country code JP in the provided data. The company operates from Japan and manufactures its hemodialysis machine cleaning agents there.
Which regulatory registry lists AMTEC Co., Ltd.'s devices?
AMTEC Co., Ltd.'s devices are listed in the Eudamed registry, which is the European database for medical devices. This listing indicates that the company's products are registered for distribution in markets governed by EU medical device regulations.
How are AMTEC Co., Ltd.'s devices classified?
AMTEC Co., Ltd.'s devices are classified as Class IIb under the medical device classification system. This classification reflects a moderate to high level of risk, requiring appropriate conformity assessment procedures before they can be placed on the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Japan
- Address
- 1-27-9, Edobori,Nishi-ku,Osaka-shi, Osaka, Japan
- Website
- www.amtecnet.co.jp/en/
- —
- —
- [email protected]
- Phone
- +81 6 6447 6555
- PRRC Contact
- Kunihito Yagi
- EUDAMED SRN
- JP-MF-000001277
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Citrix-LA | LA001 | EUDAMED | Class IIb | Active |
| NClean-CA30 | CA30_001 | EUDAMED | Class IIb | Active |
| Citrix-50H | 50H001 | EUDAMED | Class IIb | Active |
| Sanacide | EP001 | EUDAMED | Class IIb | Active |
| NClean-CA20 | CA20_001 | EUDAMED | Class IIb | Active |
| NClean-PAA | PAA_001 | EUDAMED | Class IIb | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.