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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

IUP-01 — Class I MDR by BLUEBACK

MD Atlas
BLUEBACK

EUDAMED last updated this device on Nov 15, 2024

IUP-01

3770024481IUP6S

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BLUEBACK
UDI-DI code: 03770024481082
Reference / catalog number: IUP-01

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Manufacturer information

Organization name: BLUEBACK
SRN: FR-MF-000042414
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: 03770024481082
Basic UDI-DI: 3770024481IUP6S
Reference / catalog number: IUP-01
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: L'Inner UP, le premier dispositif de biofeedback des muscles du perinée, SANS SONDE. Grâce à la Deep-EMG, vous pouvez dès maintenant visualiser les contractions et les relâchements du périnée de vos patient.es grâce à nos électrodes de surface ultra haute définitions, combinées à notre brique algorithmique innovante. Contenu: - Un boitier Bluetooth Inner UP - Une ceinture de maintien - Un câble d'électrodes Ultra HD 3.1 et sa pochette de rangement - Des patchs adhésifs pour maintenir les électrodes - Un chargeur secteur et son câble USB-C - Un kit de nettoyage. Nécessite l'installation de l'application Inner App sur une tablette compatible (Android 12 minimum, BLE 5.0).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12100401ELECTROMYOGRAPHS

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

This device is not currently linked to any other device.

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.