Technoflex Sas.
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000033888
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Technoflex Sas. makes
Technoflex Sas. manufactures empty container solutions for intravenous (IV) fluid administration, including 100ml, 250ml, 500ml, and 1000ml sizes. These products are designed as sterile, single-use containers for medical fluids, supporting hospital and clinical settings.
The company’s portfolio is classified under FDA’s Class II medical devices and is listed via the 510(k) pathway in the United States. The devices are registered under the FDA’s regulatory framework.
Catalogue
DMRX 250ml Empty Solution Container Ref DMRX02502T013.04_A
CE MDR EUDAMEDDMRX 1000ml Empty Solution Container Ref DMRX10002T007.03_A
CE MDR EUDAMEDDMRX 500 ml Empty Solution Container Ref DMRX05002T006.03_A
CE MDR EUDAMEDDMRX Empty solution container Ref DMRX01002T018.03_A
CE MDR EUDAMED- 510(k) 510(k)
Company details
- EUDAMED SRN
- FR-MF-000033888
- EU VAT number
- FR47722721339
- EUDAMED status
- Active
- EUDAMED registered name
- TECHNOFLEX
- EUDAMED abbreviated name
- TFX
- Registered address
- 69, ZA de Bassilour, 64210, BIDART, France
- Website
- www.technoflex.net
- [email protected]
- Phone
- 0607757846
- PRRC contact
- Stéphanie LAUGIER
FDA establishments
- Technoflex SAS BIDART Nouvelle-Aquitaine · FR FEI 3039404452
Frequently asked questions
How many devices does Technoflex Sas. have in the registry?
The registry currently lists 5 devices for Technoflex Sas.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Technoflex Sas.'s devices?
Among its 5 most recently registered devices, Technoflex Sas. has devices listed in EUDAMED (4 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Technoflex Sas.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Technoflex Sas.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Technoflex Sas. in the registry?
The most recently registered devices listed for Technoflex Sas. include DMRX 250ml Empty Solution Container, DMRX 1000ml Empty Solution Container, DMRX 500 ml Empty Solution Container and DMRX Empty solution container.
Which FDA establishments are linked to Technoflex Sas.?
1 FDA establishment is linked to Technoflex Sas. in the registry; they are listed on the company page.