Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

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 17, 2023

DynamX System

B-05904754910989

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Syntropiq s.r.o.
UDI-DI code: 05904754910989
Reference / catalog number: 22S16461512

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

1234456B-05904754927727On the market DynamX SystemB-05904754906104On the market DynamX SystemB-05904754906128On the market DynamX SystemB-05904754922227On the market DynamX SystemB-05904754922203On 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.

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: 05904754910989
Basic UDI-DI: B-05904754910989
Reference / catalog number: 22S16461512
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