Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Biosynex Inhalation chamber 9… — Class I MDR by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on Feb 24, 2022

Biosynex Inhalation chamber 9 months-6 years

353267F00045O82

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOSYNEX
UDI-DI code: 03532678604374
Reference / catalog number: 860437

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

1120001-50353267F00074P8GOn the market 860045B-05400606954236On the market AMAZON BASIC CARE VAGINAL INFECTIONS TESTB-05400606954229On the market 1090003B-03700531705135On the market 1090003_CB-03532670103684On the market

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 9 months-6 years
UDI-DI code: 03532678604374
Basic UDI-DI: 353267F00045O82
Reference / catalog number: 860437
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