Elltec Co., Ltd.
Active in EUDAMEDJapanfrom SRN EUDAMED SRN JP-MF-000012032
- Devices
- 4
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Elltec Co., Ltd. makes
Elltec Co., Ltd. manufactures modifications and variants of the Animec system, including models AM-2S-4, AM-2S-5, LT-1-4, and LT-1-5, which are designed for specific medical applications requiring controlled mechanical stimulation or rehabilitation.
These devices are classified as Class II under US regulations and are listed via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: CE MDD Registry: EUDAMED
Blood/Infusion Warmer Ref ANIMEC AM-301-4AF
Regimes: CE MDD Registry: EUDAMED- Regimes: 510(k) Registry: 510(k)
Animec, Models Am-2S-4 And Am-2S-5 Ref K012906
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- JP-MF-000012032
- EUDAMED status
- Active
- EUDAMED registered name
- ELLTEC Co., Ltd.
- Registered address
- Shirakawa No.6 Building, 2-18-5 Nishiki, Naka-ku, 4600003, Nagoya, Japan
- Website
- www.elltec.co.jp
- [email protected]
- Phone
- +81 522017308
- PRRC contact
- Genshiro Ogawa
Frequently asked questions
How many devices does Elltec Co., Ltd. have in the registry?
The registry currently lists 4 devices for Elltec Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elltec Co., Ltd.'s devices?
Among its 4 most recently registered devices, Elltec Co., Ltd. has devices listed in EUDAMED (2 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Elltec Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Elltec Co., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elltec Co., Ltd. in the registry?
The most recently registered devices listed for Elltec Co., Ltd. include ANIMEC AM-301-5AF, Blood/Infusion Warmer, MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 and ANIMEC, MODELS AM-2S-4 AND AM-2S-5.