- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Mar 31, 2026
B-05904109612575omegapack Ortopédiai műtéti szett 389 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by ZARYS International Spółka z ograniczoną odpowiedzialnością . Placed on the EU market in Hungary. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05904109612575OP-ORT-01389(01)05904109612575
European Medical Device Nomenclature — the EU product classification assigned to this device.
V0599CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER4 warnings recorded — scroll inside the panel to see all entries.
PL-MF-000000410HD 1023663-1Primary placement in Hungary; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| HungaryPrimary placement | — | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
59079968M02020101-ST6On the marketomegapack Laparoscopy set 113 - BARIATRICB-05904109614203On the marketomegapack Laparoscopy set 114 - LAPAROSCOPYB-05904109614241On the marketomegapack Surgical set 228 - LAPAROTOMYB-05904109614227On the marketomegapack Universal set 241 - HERNIAB-05904109613497On the marketomegapack Universeel pakket 244 - GMCB-05904109618652On the marketCertificate health across this manufacturer's portfolio.
HZ 2739190-1RestrictedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →