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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

N/A — Class I MDR by IT serve, s.r.o.

MD Atlas
IT serve, s.r.o.

EUDAMED last updated this device on Mar 18, 2026

N/A

859422444RedivalonOto01XW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: IT serve, s.r.o.
UDI-DI code: 08594224440015
Reference / catalog number: N/A

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Manufacturer information

Organization name: IT serve, s.r.o.
SRN: CZ-MF-000050657
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW999
Applied part - Speculum
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 1 country total.

Placed on the market in Czechia; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08594224440015
Basic UDI-DI: 859422444RedivalonOto01XW
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12021009DIRECT OUTPATIENT VIDEO-OTOSCOPES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.