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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

U301 — Class I MDR by Berollka-aktiv…

MD Atlas
Berollka-aktiv Rollstuhltechnik GmbH

EUDAMED last updated this device on Mar 15, 2023

U301

40663582050U3010000SJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Berollka-aktiv Rollstuhltechnik GmbH
UDI-DI code: 04066358200215
Reference / catalog number: U301

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Manufacturer information

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

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: 04066358200215
Basic UDI-DI: 40663582050U3010000SJ
Reference / catalog number: U301
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 Rookie 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
Serial number
Software identification

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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.