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Organization name
UDI-DI code
Reference / catalog number

Velara R/F 2T — Class IIb MDR by Philips Medical Systems…

MD Atlas
Philips Medical Systems DMC GmbH

EUDAMED last updated this device on Jul 25, 2025

Velara R/F 2T

0884838BM499TT

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Philips Medical Systems DMC GmbH
UDI-DI code: 00884838076143
Reference / catalog number: 989000070297

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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	Jan 13, 2012	Dec 31, 9999

Device identification

Trade name: Velara R/F 2T
UDI-DI code: 00884838076143
Basic UDI-DI: 0884838BM499TT
Reference / catalog number: 989000070297
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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