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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

Vulpés HeatBelt PRO — Class I MDR by Vulpés Electronics GmbH

MD Atlas
Vulpés Electronics GmbH

EUDAMED last updated this device on Aug 12, 2024

Vulpés HeatBelt PRO

PP13814Z1206V0354

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Vulpés Electronics GmbH
UDI-DI code: 111948611703
Reference / catalog number: VULPESKB10

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Manufacturer information

Organization name: Vulpés Electronics GmbH
SRN: DE-MF-000043675
Manufacturer status: Inactive

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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: Vulpés HeatBelt PRO
UDI-DI code: 111948611703
Basic UDI-DI: PP13814Z1206V0354
Reference / catalog number: VULPESKB10
Issuing entity: IFA

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 3000
Additional product description: The smart heated belt provides targeted warmth for the back, pelvis, and kidney area.
Additional information URL: https://www.vulpes-smartwear.com/en/products/heatbelt-pro-warming-belt-lowerback
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120602PHYSIOTHERAPY EQUIPMENT

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

VulpésPP13814Z1206V0354On the market VulpésPP13814Z1206V0354On 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.