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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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Organization name
UDI-DI code
Reference / catalog number

001_4110_111111 — Class I MDR by Theosun technologies…

MD Atlas
Theosun technologies s.r.o.

EUDAMED last updated this device on May 28, 2026

001_4110_111111

859420855001AWO104L

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Theosun technologies s.r.o.
UDI-DI code: 08594208550068
Reference / catalog number: 001_4110_111111

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View device family (Basic UDI)

Manufacturer information

Organization name: Theosun technologies s.r.o.
SRN: CZ-MF-000055012
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
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Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Dec 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594208550068
Basic UDI-DI: 859420855001AWO104L
Reference / catalog number: 001_4110_111111
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Polohovatelné ortéza zápěstí v sadě se šesti typy opor ruky
Additional information URL: https://www.theosun.cz/adamus-wo-1-0/
Clinical sizes: Levá
M
Dlouhá

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08594208550068

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y060613WRIST-HAND-FINGERS ORTHOSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.