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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

PRIM0010 — Class I MDR by andad'or GmbH

MD Atlas
andad'or GmbH

EUDAMED last updated this device on Aug 26, 2022

PRIM0010

426238662PRIM0010UW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: andad'or GmbH
UDI-DI code: 04262386620005
Reference / catalog number: PRIM0010

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Manufacturer information

Organization name: andad'or GmbH
SRN: DE-MF-000019250
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Aug 9, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262386620005
Basic UDI-DI: 426238662PRIM0010UW
Reference / catalog number: PRIM0010
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: Design Bambus Rollator
Additional information URL: https://www.andador.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y120606WHEELED WALKER

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

This device is not currently linked to any other device.

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.