Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

8001 — Class IIa MDR by Medizintechnik Behounek…

MD Atlas
Medizintechnik Behounek GmbH

EUDAMED last updated this device on Nov 21, 2023

8001

912011570LABpenMED-01BF

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medizintechnik Behounek GmbH
UDI-DI code: 09120115700013
Reference / catalog number: 8001

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: 09120115700013
Basic UDI-DI: 912011570LABpenMED-01BF
Reference / catalog number: 8001
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

8003912011570LABpenMED-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.