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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

24-001 — Class I MDR by Sphaira Medical GmbH

MD Atlas
Sphaira Medical GmbH

EUDAMED last updated this device on Aug 28, 2024

24-001

42700045162MOBYHP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sphaira Medical GmbH
UDI-DI code: 04170000193593
Reference / catalog number: 24-001

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Manufacturer information

Organization name: Sphaira Medical GmbH
SRN: DE-MF-000043892
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04170000193593
Basic UDI-DI: 42700045162MOBYHP
Reference / catalog number: 24-001
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: The MOBY P1 is a powered, mobile clean room designed to function as a mobile protective isolation unit, preventing particulate contamination of the enclosed patient (passenger) from the external environment while allowing mobility in a seated position. The MOBY P1 facilitates social interaction through tactile and visual connectivity. Additionally, the device safeguards the surrounding environment from potential particulate contamination by the passenger while maintaining their mobility. The MOBY P1 is reusable, non-invasive, and only comes into contact with the patient’s skin.
Additional information URL: https://meet-moby.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T99PROTECTIVE DEVICES AND AIDS FOR INCONTINENCE (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - 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

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.