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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

0503 0001 — Class I MDR by Integral Medical GmbH

MD Atlas
Integral Medical GmbH

EUDAMED last updated this device on Jun 23, 2023

0503 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: 04262357040047
Reference / catalog number: 0503 0001

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Manufacturer information

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

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: 04262357040047
Basic UDI-DI: 426235704DBK&DBFY8
Reference / catalog number: 0503 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
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

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0504 0001426235704DBK&DBFY8On the market 0302 000x426235704OKS20009BOn the market 0203 000x426235704OKS30009JOn the market 0305 0001426235704MT1002ZOn the market 0201 0003426235704OKSH7On 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.