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Organization name
UDI-DI code
Reference / catalog number

ŁB-N2O — Class IIb MDR by INMED Spółka Akcyjna

MD Atlas
INMED Spółka Akcyjna

EUDAMED last updated this device on Aug 21, 2025

ŁB-N2O

590435882SRGMM9

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: INMED Spółka Akcyjna
UDI-DI code: 05904358829380
Reference / catalog number: ŁB-N2O

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View device family (Basic UDI)

Manufacturer information

Organization name: INMED Spółka Akcyjna
SRN: PL-MF-000009272
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0038/4999/2025Issued
Quality management systemNotified body: 2274Expiry: Aug 6, 2028

Critical warnings

No critical warnings reported for this device.

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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: 05904358829380
Basic UDI-DI: 590435882SRGMM9
Reference / catalog number: ŁB-N2O
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)05904358829380

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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.

Z120309MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES

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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