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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

FA-RL01 — Class I MDR by SWAN MEDICAL, S.L

MD Atlas
SWAN MEDICAL, S.L

EUDAMED last updated this device on Nov 14, 2023

FA-RL01

8437016917FA-RL018U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SWAN MEDICAL, S.L
UDI-DI code: 08437016917015
Reference / catalog number: FA-RL01

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Manufacturer information

Organization name: SWAN MEDICAL, S.L
SRN: ES-MF-000001526
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Feb 14, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437016917015
Basic UDI-DI: 8437016917FA-RL018U
Reference / catalog number: FA-RL01
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: Is specifically designed to be used with the RUTILIGHT®/RUTISIDE device. Both allow lighting the surgical field in a comfortable and practical way, regardless of environment lighting. This improves the surgeon's field of vision in any condition, particularly in deep or difficult-to- access incisions. It is especially suitable for all types of open surgery, always in an operating room under normal lighting conditions.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12020499INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

RL-018437016917RL-013POn the market RS-018437016917RS-0158On the market RL-018437016917RL-013POn the market RS-018437016917RS-0158On 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.