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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

B2STUB-S — Class I MDR by BACK2SLEEP

MD Atlas
BACK2SLEEP

EUDAMED last updated this device on Jun 19, 2023

B2STUB-S

3770027709015XU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BACK2SLEEP
UDI-DI code: 03770027709015
Reference / catalog number: B2STUB-S

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Manufacturer information

Organization name: BACK2SLEEP
SRN: FR-MF-000034642
Manufacturer status: Active

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: 03770027709015
Basic UDI-DI: 3770027709015XU
Reference / catalog number: B2STUB-S
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: Silicon stent per 1 size S under blister
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 13.3 MU10

EMDN nomenclature code(s)

Q03010299ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA 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

Related devices

B2STUB-M03770027709B2SSILQGOn the market B2STUB-XL03770027709B2SSILQGOn the market B2STUB-L03770027709B2SSILQGOn the market B2STUB-S03770027709B2SSILQGOn the market B2STUB-L3770027709022XROn the market

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.