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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

KO100AM — Class I MDR by ACTION SPÓŁKA AKCYJNA

MD Atlas
ACTION SPÓŁKA AKCYJNA

EUDAMED last updated this device on Dec 3, 2025

KO100AM

5901443KOT5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ACTION SPÓŁKA AKCYJNA
UDI-DI code: 05901443410850
Reference / catalog number: KO100AM

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View device family (Basic UDI)

Manufacturer information

Organization name: ACTION SPÓŁKA AKCYJNA
SRN: PL-MF-000046182
Manufacturer status: Active

Related devices

CH200AM5901443CH200AM6ZOn the market PM200AM5901443PMTGOn the market PM100AM5901443PMTGOn the market DW100AM5901443DWSYOn the market KP600AM5901443KP600AMFVOn 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

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 Poland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05901443410850
Basic UDI-DI: 5901443KOT5
Reference / catalog number: KO100AM
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: 150 x 200 cm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05901443410850

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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.

V9099VARIOUS 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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