Question 1

How many devices does Tianjin Uwell Medical Device Manufacturing Co., Ltd. have in the registry?

Accepted Answer

The registry currently lists 17 devices for Tianjin Uwell Medical Device Manufacturing Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Question 2

Which registries list Tianjin Uwell Medical Device Manufacturing Co., Ltd.'s devices?

Accepted Answer

Among its 17 most recently registered devices, Tianjin Uwell Medical Device Manufacturing Co., Ltd. has devices listed in EUDAMED (15 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.

Question 3

What risk classes do Tianjin Uwell Medical Device Manufacturing Co., Ltd.'s devices fall under?

Accepted Answer

Among its 17 most recently registered devices, the classes recorded for Tianjin Uwell Medical Device Manufacturing Co., Ltd.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.

Question 4

What EUDAMED certificates are recorded for Tianjin Uwell Medical Device Manufacturing Co., Ltd.?

Accepted Answer

EUDAMED lists 1 certificate for Tianjin Uwell Medical Device Manufacturing Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 6 Jul 2026.

Question 5

What are the newest devices from Tianjin Uwell Medical Device Manufacturing Co., Ltd. in the registry?

Accepted Answer

The most recently registered devices listed for Tianjin Uwell Medical Device Manufacturing Co., Ltd. include Sterile Trocars for Single Use, Sterile Veress Insufflation Needles for Single Use, Sterile Trocar for Single Use and U-Blade Veress Needle.

Tianjin Uwell Medical Device Manufacturing Co., Ltd.

At a glance

EU certificates

Market reach

Catalogue17

Sterile Trocars for Single Use Ref SIG5LT

Sterile Trocars for Single Use Ref IG5XT

Sterile Trocars for Single Use Ref SIG5XT

Sterile Veress Insufflation Needles for Single Use Ref BV150

Sterile Trocars for Single Use Ref SIG5ST

Sterile Trocars for Single Use Ref IG5ST

Sterile Trocars for Single Use Ref IG5LT

Sterile Trocar for Single Use Ref BIG10LT

U-Blade Veress Needle Ref K162648

U-IGNITE Bladeless Trocar Ref K162387

Sterile Veress Insufflation Needles for Single Use Ref BV120

Sterile Trocars for Single Use Ref IG10LTPA

Sterile Trocar for Single Use Ref IGD12LTPA

Sterile Trocars for Single Use Ref IG12LTPA

Sterile Trocar for Single Use Ref IGD12LT-O

Sterile Trocar for Single Use Ref BIG10LT-CS

Sterile Trocar for Single Use Ref IGD5LT

Company details

EUDAMED certificates1

TÜV Rheinland LGA Products GmbH 0197 1 certificate

Frequently asked questions