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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

KT-1034490BeGR , SPN-1028790BeGR — Class IIb MDR

MD Atlas
Lumenis (Germany) GmbH

EUDAMED last updated this device on May 11, 2026

KT-1034490BeGR , SPN-1028790BeGR

426053918APSCN8F

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lumenis (Germany) GmbH
UDI-DI code: 04260539182172
Reference / catalog number: KT-1034490BeGR , SPN-1028790BeGR

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Manufacturer information

Organization name: Lumenis (Germany) GmbH
SRN: DE-MF-000007655
Manufacturer status: Active

Related devices

KT-20113790GR426053918MAPFL8YOn the market KT-20113720GR426053918MAPFL8YOn the market KT-20113830GR426053918MAPFL8YOn the market KT-20116590GR426053918MAPFL8YOn the market KT-20113800GR426053918MAPFL8YOn 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

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260539182172
Basic UDI-DI: 426053918APSCN8F
Reference / catalog number: KT-1034490BeGR , SPN-1028790BeGR
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.

EMDN nomenclature code(s)

Z12011080LASER SURGERY INSTRUMENTS - HARDWARE 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification