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U-Needle B.V.

Country not established FDA establishment FEI 3009853488

Devices
1
Registrations
FDA
FDA recalls
0

Catalogue1

Newest first, rows 1-1 of 1

  • Bella-mu Ref K190962

    Class II
    Active 510(k) 510(k) II

Company details

FDA FEI number
3009853488
Address
De Veldmaat 10, Enschede Overijssel

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • U-Needle B.V. US

Frequently asked questions

How many devices does U-NEEDLE B.V. have in the registry?

The registry currently lists 1 device for U-NEEDLE B.V.. Devices recorded under merged duplicate company entries are counted once.

Which registries list U-NEEDLE B.V.'s devices?

Among its 1 most recently registered device, U-NEEDLE B.V. has devices listed in FDA 510(k) (1 device).

What risk classes do U-NEEDLE B.V.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for U-NEEDLE B.V.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from U-NEEDLE B.V. in the registry?

The most recently registered devices listed for U-NEEDLE B.V. include Bella-mu.

Which FDA establishments are linked to U-NEEDLE B.V.?

1 FDA establishment is linked to U-NEEDLE B.V. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.