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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

ISA 9000 — Class IIb MDR by Zakład Techniki…

MD Atlas
Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.

EUDAMED last updated this device on May 21, 2026

ISA 9000

5904126-Panele/HK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.
UDI-DI code: 05904126006210
Reference / catalog number: ISA 9000

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View device family (Basic UDI)

Manufacturer information

Organization name: Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.
SRN: PL-MF-000009262
Manufacturer status: Active

Related devices

SR15904126-SR/VPOn the market SR15904126-SR/VPOn the market SR25904126-SR/VPOn the market A1-B5904126-A/75On the market ISA 9000su5904126-Panele/HKOn the market

Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0044/1127/2025Supplemented
Quality management systemNotified body: 2274Expiry: Dec 7, 2028
TNP/MDR/0004/1127/2022Amended
Quality management systemNotified body: 2274Expiry: Dec 7, 2025

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05904126006210
Basic UDI-DI: 5904126-Panele/HK
Reference / catalog number: ISA 9000
Issuing entity: GS1

Classification

Risk category: Class IIb
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05904126006210

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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.

Z129017BED HEAD UNITS

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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