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TSE spol. s r.o.

Czechia CZ-MF-000026442 Last updated 17 Sep 2026

Devices
5
Registries
EUDAMED
FDA recalls
0

Catalogue5

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 1023 1 certificate

  • 26 0299 QR/NB Issued

    Quality management system EU MDR

    Issued
    30 Sep 2026
    Expires
    29 Sep 2031

Related companies

Notified bodies

  • Notified body 1023

What TSE spol. s r.o. makes

TSE spol. s r.o. manufactures medical devices including the SHELLY, LiLLY, and NATALLY series, as well as the 11FY95033G product and an infant phototherapeutic device for neonatal care. These products cover diagnostic and therapeutic applications, with some designed for specific patient populations like newborns.

The company’s portfolio includes devices classified as Class IIa and Class IIb under EU regulations, all of which are registered in the eudamed database. The manufacturer is based in the Czech Republic and adheres to EU medical device compliance requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does TSE spol. s r.o. manufacture?

TSE spol. s r.o. produces a range of medical devices including diagnostic and therapeutic products. Their portfolio includes the SHELLY, LiLLY, and NATALLY series, as well as the 11FY95033G product and an infant phototherapeutic device specifically designed for neonatal care. These devices cater to different medical needs, such as monitoring and treating newborns.

Where is TSE spol. s r.o. based?

TSE spol. s r.o. is based in the Czech Republic. The company operates from this location while developing and manufacturing its medical devices in compliance with EU regulatory standards.

Which regulatory registries list TSE spol. s r.o.’s devices?

TSE spol. s r.o.’s medical devices are registered in the eudamed database, which is the official EU registry for medical device information. This ensures transparency and traceability of their products under EU regulations.

How are TSE spol. s r.o.’s devices classified under EU regulations?

TSE spol. s r.o.’s devices are classified as Class IIa and Class IIb under EU medical device regulations. This classification is based on their intended purpose and risk level, with Class IIa and IIb requiring stricter compliance measures than lower-risk devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Czechia
Address
390/74, Mánesova, České Budějovice, Czechia
Phone
+420 386 721 161
PRRC contact
Vojtěch Kamenský
EUDAMED SRN
CZ-MF-000026442