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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

Embout buccal 22M/15F — Class I MDR by Int'Air Médical

MD Atlas
Int'Air Médical

EUDAMED last updated this device on Mar 30, 2022

Embout buccal 22M/15F

3666256DI100AP0VENU0802SX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Int'Air Médical
UDI-DI code: 03666256010988
Reference / catalog number: AC26

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Manufacturer information

Organization name: Int'Air Médical
SRN: FR-MF-000000328
Manufacturer status: Active

Critical warnings

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

CW008
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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: Embout buccal 22M/15F
UDI-DI code: 03666256010988
Basic UDI-DI: 3666256DI100AP0VENU0802SX
Reference / catalog number: AC26
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: 22M/15F

EMDN nomenclature code(s)

R9001RESPIRATORY MOUTHPIECES

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.