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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

5855628 — Class IIb MDR by GE Medical Systems SCS

MD Atlas
GE Medical Systems SCS

EUDAMED last updated this device on Mar 5, 2026

5855628

8406821BUG00099HR

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GE Medical Systems SCS
UDI-DI code: 00195278215543
Reference / catalog number: 5855628

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Manufacturer information

Organization name: GE Medical Systems SCS
SRN: FR-MF-000000687
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jul 1, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 00195278215543
Basic UDI-DI: 8406821BUG00099HR
Reference / catalog number: 5855628
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.gehealthcare.com/support/manuals
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11030102STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES

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

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.