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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

ORTEX 032 Shoulder brace — Class I MDR by ORTEX , spol. s r.o.

MD Atlas
ORTEX , spol. s r.o.

EUDAMED last updated this device on May 31, 2026

ORTEX 032 Shoulder brace

85955714ORTEX032ND

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTEX , spol. s r.o.
UDI-DI code: 08595571404583
Reference / catalog number: N/A

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View device family (Basic UDI)

Manufacturer information

Organization name: ORTEX , spol. s r.o.
SRN: CZ-MF-000048500
Manufacturer status: Active

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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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: ORTEX 032 Shoulder brace
UDI-DI code: 08595571404583
Basic UDI-DI: 85955714ORTEX032ND
Reference / catalog number: N/A
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: The brace is designed for shoulder joint fixation.
Additional information URL: https://www.ortexzlin.cz/
Clinical sizes: S

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08595571404583

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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.

Y060621SHOULDER 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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