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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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SHELLY — 1 UDI-DI variant, MDD (TSE spol. s r.o.)

MD Atlas
TSE spol. s r.o.

Data from EUDAMED, last updated May 31, 2026

SHELLY

B-08594216240005

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIb

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Manufacturer: TSE spol. s r.o.

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Device characteristics

Active deviceMeasuring function

Legacy certificates

Certificate number: MED200066
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p. (1014)
Validity: Dec 31, 2028

Identity & classification

Basic UDI-DI: B-08594216240005
Device name: SHELLY
Device model: SI-610-1
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Version date: May 28, 2026

Manufacturer & authorised representative

Manufacturer

Name: TSE spol. s r.o.
SRN: CZ-MF-000026442
Country: Czechia
Email: medical@tse.cz
Phone: +420 386 721 161

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01KSPSQJH4DTX00R1S31E48GA5

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

SHELLY08594216240005