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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

SA-20109730BeGR, UG-2010701GR — Class IIb MDR

MD Atlas
Lumenis (Germany) GmbH

EUDAMED last updated this device on Apr 15, 2026

SA-20109730BeGR, UG-2010701GR

426053918UPKTEZ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lumenis (Germany) GmbH
UDI-DI code: 04260539181137
Reference / catalog number: SA-20109730BeGR, UG-2010701GR

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Manufacturer information

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

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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

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

CW013
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW273
EUDAMED did not publish a description for this code.
CW016
EUDAMED did not publish a description for this code.
CW169
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW275
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: 04260539181137
Basic UDI-DI: 426053918UPKTEZ
Reference / catalog number: SA-20109730BeGR, UG-2010701GR
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: The Stellar M22™ ResurFX™ Module Upgrade Kit includes a fiber‑laser based ResurFX module and associated accessories, which may be supplied as standard equipment with Stellar M22 RFX configurations or purchased as an optional upgrade for the Stellar M22 System. The upgrade integrates a dedicated controller board, scanner controller and cooling system to enable modulated laser output up to 15 W at 1565 nm, delivered through the ResurFX handpiece.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011019MULTI–PLATFORM LASER

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
Serial number
Software identification