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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

40415 — Class I MDR by Laserneedle GmbH

MD Atlas
Laserneedle GmbH

EUDAMED last updated this device on Feb 1, 2023

40415

426064916404XXU6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laserneedle GmbH
UDI-DI code: 04260649160657
Reference / catalog number: 40415

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Manufacturer information

Organization name: Laserneedle GmbH
SRN: DE-MF-000023539
Manufacturer status: Active

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LASERNEEDLE TouchB-04260649160039On the market LASERNEEDLE TouchB-04260649160008On the market LASERNEEDLE TouchB-04260649160091On the market LASERNEEDLE TouchB-04260649160060On the market 40120426064916401XXTPOn 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.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04260649160657
Basic UDI-DI: 426064916404XXU6
Reference / catalog number: 40415
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Accessory, silicone applicators are used to attach the optical fibers distal tip to the skin of the patient
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z129099VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER

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

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Manufacturing date
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Software identification