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Organization name
UDI-DI code
Reference / catalog number

RO 1750 ROT 360 — Class IIb MDR by Philips Medical Systems…

MD Atlas
Philips Medical Systems DMC GmbH

EUDAMED last updated this device on Nov 14, 2024

RO 1750 ROT 360

0884838BM495TK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Philips Medical Systems DMC GmbH
UDI-DI code: 00884838089952
Reference / catalog number: 989000086112

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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: RO 1750 ROT 360
UDI-DI code: 00884838089952
Basic UDI-DI: 0884838BM495TK
Reference / catalog number: 989000086112
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: 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)

Z11039012X-RAY TUBE ASSEMBLY

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
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Software identification