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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

PHYSIODOSE Mouche bébé avec filtre — Class I MDR

MD Atlas
Laboratoires Gilbert

EUDAMED last updated this device on Dec 3, 2021

PHYSIODOSE Mouche bébé avec filtre

3518640000387S

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratoires Gilbert
UDI-DI code: 03518646267086
Reference / catalog number: 626708

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Manufacturer information

Organization name: Laboratoires Gilbert
SRN: FR-MF-000001710
Manufacturer status: Active

Critical warnings

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

CW032
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW999
Remplacer le mouche bébé et/ou l'embout dès le moindre signe d'usure ou de détérioration. Ne pas mettre à bouillir. Demandez conseil à votre pharmacien. Si les symptômes persistent ou s'accentuent, consultez votre médecin. Veuillez rapporter tout incident grave survenu en lien avec ce dispositif aux Laboratoires Gilbert - site internet : www.labogilbert.fr et/ou à l'Autorité Compétente nationale.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: PHYSIODOSE Mouche bébé avec filtre
UDI-DI code: 03518646267086
Basic UDI-DI: 3518640000387S
Reference / catalog number: 626708
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)

Q030199NASOPHARYNGEAL 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.