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

N/A — Class IIb MDD by Idrom LT S.L.

MD Atlas
Idrom LT S.L.

EUDAMED last updated this device on Oct 25, 2021

N/A

B-ATENEA_DIODE_LASERLN

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Idrom LT S.L.
UDI-DI code: D-ATENEA_DIODE_LASERLN
Reference / catalog number: N/A

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: Idrom LT S.L.
SRN: ES-MF-000001095
Manufacturer status: Active

Critical warnings

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

CW013
La luz láser representa un peligro potencial para los ojos. Tome las precauciones necesarias en el entorno donde utilizará Atenea. USRA GAFAS DE PROTECCIÓN OCULAR PARA RADIACIÓN LASER

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jul 29, 2020	Jan 13, 2024

Device identification

Trade name: not provided
UDI-DI code: D-ATENEA_DIODE_LASERLN
Basic UDI-DI: B-ATENEA_DIODE_LASERLN
Reference / catalog number: N/A
Issuing entity: EUDAMED

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC 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

This device is not currently linked to any other device.

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.