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Organization name
UDI-DI code
Reference / catalog number

Biosynex Inhalation chamber 0-9… — Class I MDR by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on Jan 26, 2022

Biosynex Inhalation chamber 0-9 months

353267F00045O82

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOSYNEX
UDI-DI code: 03532678604367
Reference / catalog number: 860436

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Manufacturer information

Organization name: BIOSYNEX
SRN: FR-MF-000014073
Manufacturer status: Active

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Critical warnings

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

CW275
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW020
EUDAMED did not publish a description for this code.
CW012
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: Biosynex Inhalation chamber 0-9 months
UDI-DI code: 03532678604367
Basic UDI-DI: 353267F00045O82
Reference / catalog number: 860436
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)

R03010302AEROSOL PORTABLE INHALERS

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

Certificate health across this manufacturer's portfolio.

030/MDRIssued
Quality management systemNotified body: 0051Expiry: Jun 5, 2027
G10 002187 0009Issued
Quality management systemNotified body: 0123Expiry: Sep 25, 2028