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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

ORBIS Clinical Support — Class IIa MDR by DH Healthcare GmbH

MD Atlas
DH Healthcare GmbH

EUDAMED last updated this device on Feb 6, 2025

ORBIS Clinical Support

426069399OCLINSUPPORTY3

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DH Healthcare GmbH
UDI-DI code: 04260693990057
Reference / catalog number: ORBIS Clinical Support

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Manufacturer information

Organization name: DH Healthcare GmbH
SRN: DE-MF-000009069
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jun 6, 2024	Still on market
Austria	Jun 6, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260693990057
Basic UDI-DI: 426069399OCLINSUPPORTY3
Reference / catalog number: ORBIS Clinical Support
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: The product ORBIS Clinical Support is designed to provide a nursing care plan proposal based on assessment results. The import sets implement proposal rules and a catalog system as extension of a specific assessment. The basis of proposals is a scientific valid guideline or recommendation, which is provided with the product or created by the responsible of the hospital with appropriate clinical competence.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120499GENERAL MEDICINE 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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Certificates

Certificate health across this manufacturer's portfolio.

28620120401Issued
Quality management systemNotified body: 2862Expiry: Mar 13, 2027