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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

Certeray iX — Class IIb MDR by Philips Medical Systems…

MD Atlas
Philips Medical Systems DMC GmbH

EUDAMED last updated this device on Nov 28, 2024

Certeray iX

0884838BM500SK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Philips Medical Systems DMC GmbH
UDI-DI code: 00884838099425
Reference / catalog number: 989000065361

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Manufacturer information

Organization name: Philips Medical Systems DMC GmbH
SRN: DE-MF-000005362
Manufacturer status: Active

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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.

Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	May 28, 2020	Dec 31, 9999

Device identification

Trade name: Certeray iX
UDI-DI code: 00884838099425
Basic UDI-DI: 0884838BM500SK
Reference / catalog number: 989000065361
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: generator for x-ray tube
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11039011HIGH VOLTAGE X-RAY GENERATORS

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

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