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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

0504 0001 — Class I MDR by Integral Medical GmbH

MD Atlas
Integral Medical GmbH

EUDAMED last updated this device on Jun 23, 2023

0504 0001

426235704DBK&DBFY8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Integral Medical GmbH
UDI-DI code: 04262357040054
Reference / catalog number: 0504 0001

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Manufacturer information

Organization name: Integral Medical GmbH
SRN: DE-MF-000006198
Manufacturer status: Active

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0503 0001426235704DBK&DBFY8On the market 0302 000x426235704OKS20009BOn the market 0203 000x426235704OKS30009JOn the market 0305 0001426235704MT1002ZOn the market 0201 0003426235704OKSH7On the market

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: 04262357040054
Basic UDI-DI: 426235704DBK&DBFY8
Reference / catalog number: 0504 0001
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: Bucky with Cassette Tray - for DR- or CR-Cassettes with the size from 18cm x 24cm to 43cm x 43cm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11030599RADIOLOGY INSTRUMENTS - 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

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.