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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 9001S — 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 9001S

B-08594231950019

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ONYX CZ, s.r.o.
UDI-DI code: 08594231950019
Reference / catalog number: PPS 9001S

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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 strong electromagnetic interference, ionising radiation or strong electrostatic field. Do not expose the device to strong light, UV or IR radiation.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	May 19, 1998	Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594231950019
Basic UDI-DI: B-08594231950019
Reference / catalog number: PPS 9001S
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 9001B-08594231950002On 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.