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Back2Sleep pack S

by BACK2SLEEP EUDAMED

Active European Union

Ref B2SPAC-SModel Back2Sleep pack S

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770027709060XZ Basic UDI-DIDate19 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Back2Sleep Kit
Model / Reference
Back2Sleep pack S, B2SPAC-S
Primary DI / UDI-DI
03770027709060, 03770027709145
Basic UDI-DI
3770027709060XZ, 3770027709008XX
EMDN Code
Q03010299 Antisnoring and obstructive sleep apnoea devices - other
Device Class
Class I
Medical Purpose
Back2Sleep pack S
Treatment of Obstructive Sleep Apnea (OSA) and snoring

Manufacturer details

EUDAMED SRN
FR-PR-000034641

From the manufacturer

Manufacturer's product page: Size S

Other devices from BACK2SLEEP

See all devices from BACK2SLEEP →

Properties

Other properties (1)

  • Sterile: No