- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jul 10, 2026
B-05907996858385omegapack Zestaw do laparoskopii 42-LAPAROSKOPIA.GIN 1 + SSAK 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 Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05907996858385OP-LAP-00842PL-MF-000000410HD 1023663-1(01)05907996858385
3 warnings recorded — scroll inside the panel to see all entries.
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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Poland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
V0599CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHERPrimary 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 →B-05907996828715On the marketomegapack Zestaw do laparoskopii 39B-05907996860135On the marketomegapack Zestaw do laparoskopii 41B-05907996840267On the marketomegapack Zestaw do laparoskopii 43 - LAPAROSKOPIA.GIN 1B-05907996858408On the marketomegapack Zestaw do laparoskopii 45 - LAPAROTOMIAB-05907996871230On the marketomegapack Zestaw do laparoskopii 46B-05907996871254On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate 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.
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