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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

DynamX System — Class IIb MDD by Syntropiq s.r.o.

MD Atlas
Syntropiq s.r.o.

EUDAMED last updated this device on Jan 16, 2023

DynamX System

B-05904754916790

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Syntropiq s.r.o.
UDI-DI code: 05904754916790
Reference / catalog number: 2322290709

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Manufacturer information

Organization name: Syntropiq s.r.o.
SRN: CZ-MF-000010050
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.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW001
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW026
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	May 15, 2019	Still on market
Poland	May 15, 2019	Still on market

Device identification

Trade name: DynamX System
UDI-DI code: 05904754916790
Basic UDI-DI: B-05904754916790
Reference / catalog number: 2322290709
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)

P09070101SPINAL CAGES

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