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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

20013001CZ — Class I MDR by Hayne Polska Sp. z o.o.

MD Atlas
Hayne Polska Sp. z o.o.

EUDAMED last updated this device on Oct 11, 2024

20013001CZ

59076755320010101L2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hayne Polska Sp. z o.o.
UDI-DI code: 05907675535354
Reference / catalog number: 20013001CZ

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View device family (Basic UDI)

Manufacturer information

Organization name: Hayne Polska Sp. z o.o.
SRN: PL-MF-000044330
Manufacturer status: Active

Related devices

2001530159076755320010101L2On the market 20013001IT59076755320010101L2On the market 20013101CZ59076755320010101L2On the market 20013001LV59076755320010101L2On the market 20013101LV59076755320010101L2On 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

No critical warnings reported for this device.

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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: 05907675535354
Basic UDI-DI: 59076755320010101L2
Reference / catalog number: 20013001CZ
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: language of the label: CZ
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 30 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05907675535354

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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.

V0799PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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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