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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

RF01 — Class I MDR by AUTANA FARMACOS, SL

MD Atlas
AUTANA FARMACOS, SL

EUDAMED last updated this device on Dec 18, 2024

RF01

8437023937RFJR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AUTANA FARMACOS, SL
UDI-DI code: 08437023937013
Reference / catalog number: RF01

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Manufacturer information

Organization name: AUTANA FARMACOS, SL
SRN: ES-MF-000014847
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08437023937013
Basic UDI-DI: 8437023937RFJR
Reference / catalog number: RF01
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: Producto sanitario cuya finalidad prevista es ser utilizado como irrigador nasal en casos de rinitis y sinusitis producidas por alergias e infecciones, congestión nasal, cuidados postquirúrgicos y limpieza de los senos paranasales.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q030103NASAL IRRIGATION SOLUTIONS

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

RF008437023937RFJROn the market 00184370239370014AOn the market 00384370239370034EOn the market 00284370239370024COn 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.