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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

8003 — Class IIa MDR by Medizintechnik Behounek…

MD Atlas
Medizintechnik Behounek GmbH

EUDAMED last updated this device on Nov 21, 2023

8003

912011570LABpenMED-01BF

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medizintechnik Behounek GmbH
UDI-DI code: 09120115700037
Reference / catalog number: 8003

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Manufacturer information

Organization name: Medizintechnik Behounek GmbH
SRN: AT-MF-000022520
Manufacturer status: Active

Critical warnings

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

CW084
Laserlicht kann das Auge irreparabel schädigen! WARNUNG – LASERSTRAHLUNG, NICHT DEM STRAHL AUSSETZEN LASER KLASSE 3B

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Aug 11, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 09120115700037
Basic UDI-DI: 912011570LABpenMED-01BF
Reference / catalog number: 8003
Issuing entity: GS1

Classification

Risk category: Class IIa
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)

Z120615THERAPEUTIC LASERS

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

Related devices

8001912011570LABpenMED-01BFOn the market 8002912011570LABpenMED-01BFOn 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.