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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

XB01 — Class I MDR by XenoPatch GmbH

MD Atlas
XenoPatch GmbH

EUDAMED last updated this device on Oct 2, 2024

XB01

426248725XB01BA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: XenoPatch GmbH
UDI-DI code: 04262487250002
Reference / catalog number: XB01

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Manufacturer information

Organization name: XenoPatch GmbH
SRN: DE-MF-000041532
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
All warnings er explained in IFU

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: 04262487250002
Basic UDI-DI: 426248725XB01BA
Reference / catalog number: XB01
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: Der XenoBelt ermöglicht die effiziente und präzise Anwendung von Wärme-, Kälte-, Kontrast- und Vibrationsbehandlungen. Durch das XenoPatch-System können diese Anwendungen ohne den Einsatz von Eis und Wasser durchgeführt werden. Der XenoBelt ist vielseitig einsetzbar und kann von qualifizierten Fachkräften an verschiedenen Körperstellen angewendet werden. Dies ermöglicht eine individuelle Anpassung und Komfortsteigerung für den Patienten.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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

XH01426248725XH01C8On 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.