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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

143130 — Class I MDR by QUIES SAS

MD Atlas
QUIES SAS

EUDAMED last updated this device on Sep 11, 2023

143130

343517HC001W6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: QUIES SAS
UDI-DI code: 03435171431303
Reference / catalog number: 143130

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Manufacturer information

Organization name: QUIES SAS
SRN: FR-MF-000009589
Manufacturer status: Active

Critical warnings

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

CW010
Keep out of the reach and sight of children. If you experience ear pain, consult your doctor. In case of contact with mucous membranes, rinse with plenty of water. In case of doubt about the use of the device, ask your doctor for advice. In case of serious incident involving this device in connection with this device, contact quies@quies.com and inform the relevant authority.
CW011
Do not use in cases of otitis, perforation of the tympanic membrane in patients with transtympanic aerators or after ear surgery. Do not use in case of known allergy to any of the components. Do not use on injured skin.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03435171431303
Basic UDI-DI: 343517HC001W6
Reference / catalog number: 143130
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q03040299EAR IRRIGATION DEVICES - 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

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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.