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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

N16CAAA1KDUHAIB00008 — Class I MDR by CLINITEX s.r.o.

MD Atlas
CLINITEX s.r.o.

EUDAMED last updated this device on Jan 23, 2026

N16CAAA1KDUHAIB00008

859420696CLIX002SH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CLINITEX s.r.o.
UDI-DI code: 08594206966786
Reference / catalog number: N16CAAA1KDUHAIB00008

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Manufacturer information

Organization name: CLINITEX s.r.o.
SRN: CZ-MF-000051598
Manufacturer status: Active

Related devices

N04AAAA1NDIHAXX00108859420696CLIX003SKOn the market N04AAAA1NDIHAXX00008859420696CLIX003SKOn the market N04AAAA1NDIHAXX00908859420696CLIX003SKOn the market N04AAAA1NDIHAXX00109859420696CLIX003SKOn the market N04AAAA1NDIHAXX00009859420696CLIX003SKOn the market

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

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

CW999
Nepoužívat aviváž
CW999
Do not use fabric softener
CW010
EUDAMED did not publish a description for this code.

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: not provided
UDI-DI code: 08594206966786
Basic UDI-DI: 859420696CLIX002SH
Reference / catalog number: N16CAAA1KDUHAIB00008
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: 2XL
Základní
světle modrá/tmavě zelená

EMDN nomenclature code(s)

T020402REINFORCED SURGICAL GOWNS

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