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Organization name
UDI-DI code
Reference / catalog number

LS03500-AABB — Class IIb MDR by A.R.C. Laser GmbH

MD Atlas
A.R.C. Laser GmbH

EUDAMED last updated this device on Jan 22, 2024

LS03500-AABB

426015559FOXIV9R

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: A.R.C. Laser GmbH
UDI-DI code: 04260155593260
Reference / catalog number: LS03500-AABB

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Manufacturer information

Organization name: A.R.C. Laser GmbH
SRN: DE-MF-000009383
Manufacturer status: Active

Related devices

LS09010-S426015559CITO5329NOn the market LS09011-DS426015559COBRA4TOn the market LS09011-LS426015559COBRA4TOn the market LS03500-BWAA426015559FOXIV9ROn the market LS03500-BWAB426015559FOXIV9ROn the market

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW012
EUDAMED did not publish a description for this code.
CW013
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Spain		Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260155593260
Basic UDI-DI: 426015559FOXIV9R
Reference / catalog number: LS03500-AABB
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: 810 MU66

EMDN nomenclature code(s)

Z12011016DIODE SURGICAL 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

Certificates

Certificate health across this manufacturer's portfolio.

G10 002848 0008Issued
Quality management systemNotified body: 0123Expiry: Jul 24, 2028