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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

U4401 — Class I MDR by Berollka-aktiv…

MD Atlas
Berollka-aktiv Rollstuhltechnik GmbH

EUDAMED last updated this device on Mar 15, 2023

U4401

40663582050U4400000UC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Berollka-aktiv Rollstuhltechnik GmbH
UDI-DI code: 04066358200116
Reference / catalog number: U4401

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Manufacturer information

Organization name: Berollka-aktiv Rollstuhltechnik GmbH
SRN: DE-MF-000007043
Manufacturer status: Active

Related devices

U20040663582050U2000000RNOn the market U20140663582050U2000000RNOn the market U20240663582050U2000000RNOn the market U20340663582050U2000000RNOn the market 90040663581020900000004POn 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.

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: not provided
UDI-DI code: 04066358200116
Basic UDI-DI: 40663582050U4400000UC
Reference / catalog number: U4401
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 Tourer is a seating shell mobility base that is intended to provide mobility in daily life to person who are unable to walk or have difficulty in walking.
Additional information URL: https://www.berollka.de/
Clinical sizes: 0–120 MU29

EMDN nomenclature code(s)

Y122103PUSH WHEELCHAIRS

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
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Software identification