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Organization name
UDI-DI code
Reference / catalog number

dicomPACS® — Class IIa MDR by Oehm und Rehbein GmbH

MD Atlas
Oehm und Rehbein GmbH

EUDAMED last updated this device on Jul 30, 2024

dicomPACS®

42508029L10003C

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oehm und Rehbein GmbH
UDI-DI code: 04250802900022
Reference / catalog number: L1000

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Manufacturer information

Organization name: Oehm und Rehbein GmbH
SRN: DE-MF-000004977
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: dicomPACS®
UDI-DI code: 04250802900022
Basic UDI-DI: 42508029L10003C
Reference / catalog number: L1000
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: All types of images (X-rays, CT, MRI, digital camera, ultrasound) as well as all kinds of documents (doctors' letters, diagnoses, recovery processes, faxes) can be acquired, diagnosed and then filed in the digital patient file only one mouse click away, with dicomPACS®.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11031182SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - SOFTWARE ACCESSORIES

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.

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