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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

VRP_001 — Class I MDR by VR LIFE s.r.o.

MD Atlas
VR LIFE s.r.o.

EUDAMED last updated this device on Mar 14, 2024

VRP_001

859421497VRVITALISPROU9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VR LIFE s.r.o.
UDI-DI code: 08594214970041
Reference / catalog number: VRP_001

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Manufacturer information

Organization name: VR LIFE s.r.o.
SRN: CZ-MF-000040304
Manufacturer status: Active

Critical warnings

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

CW010
The application can only be used after proper familiarization with the general conditions and instructions for use, which are available in the application´s administration. Terms and conditions and information on personal data processing are also available in the application´s administration, and the customer is acquainted with them during registration.

Market distribution

Primary placement in Czechia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08594214970041
Basic UDI-DI: 859421497VRVITALISPROU9
Reference / catalog number: VRP_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: VR VITALIS Pro® - Physical, logopedic, psychological and cognitive rehabilitation in virtual reality under the supervision of qualified personnel.
Additional information URL: https://vrvitalis.cz/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

VRP_005859421497VRVITALISPROU9On the market VRP_004859421497VRVITALISPROU9On the market VRP_003859421497VRVITALISPROU9On the market VRP_002859421497VRVITALISPROU9On 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.