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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

PPS 9001 — Class IIb MDD by ONYX CZ, s.r.o.

MD Atlas
ONYX CZ, s.r.o.

EUDAMED last updated this device on May 13, 2026

PPS 9001

B-08594231950002

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ONYX CZ, s.r.o.
UDI-DI code: 08594231950002
Reference / catalog number: PPS 9001

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Manufacturer information

Organization name: ONYX CZ, s.r.o.
SRN: CZ-MF-000007837
Manufacturer status: Active

Critical warnings

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

CW999
Do not use the device in areas with sources of strong electromagnetic interference, ionizing radiation or in a strong electrostatic field. Do not expose the device to strong light sources, UV or IR radiation.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Sep 18, 1997	Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594231950002
Basic UDI-DI: B-08594231950002
Reference / catalog number: PPS 9001
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030302SYRINGE PUMPS

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

Related devices

PPS 9001SB-08594231950019On the market

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.