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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

PT802 — Class IIa MDR by LABORATOIRES QUINTON…

MD Atlas
LABORATOIRES QUINTON INTERNATIONAL S.L.

EUDAMED last updated this device on Aug 5, 2025

PT802

843700464900137

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LABORATOIRES QUINTON INTERNATIONAL S.L.
UDI-DI code: 08470001783851
Reference / catalog number: PT802

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Manufacturer information

Organization name: LABORATOIRES QUINTON INTERNATIONAL S.L.
SRN: ES-MF-000004083
Manufacturer status: Active

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Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW135
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW999
El uso de este producto en otras patologías ORL no ha sido evaluado. Consulte con su médico en caso de que los síntomas persistan o sean diferentes a los descritos en el producto. No utilice el producto si observa daños en el envase, pérdida de presión o si no se libera la solución de manera adecuada.
CW268
EUDAMED did not publish a description for this code.
CW157
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	Aug 1, 2025	Jul 13, 2029

Device identification

Trade name: not provided
UDI-DI code: 08470001783851
Basic UDI-DI: 843700464900137
Reference / catalog number: PT802
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)

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

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.