- Role
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IT-MF-000007965EPT 0477.MDD.20/3822.1Dr. Max Healing Gel 20 ml CZ, SK, PL, RO, SRB, IT is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Labomar S.p.A.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 13, 2026
B-FTP042_2JEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-FTP042_2JE
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
1 warning recorded — scroll inside the panel to see all entries.
CW999Sterile
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 Czechia; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Italy | — | Still on market |
| Poland | — | Still on market |
| Romania | — | Still on market |
| Slovakia | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-FTP042_2JEBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-FTP042_2JEFTP042UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHERNo certificate specifically references this device's Basic UDI-DI.
B-FTP054_9KDOn the marketDoppelherz aktiv Iritakolin BGB-FTP054_8KBOn the marketDoppelherz med Na drażliwe jelita PLB-FTP054_2JXOn the marketEASYHALS ATB-FTP081_2K5On the marketENDOCOL ITB-FTP054_108JOn the marketEva Intima Cervasil 30 ml GR, CY, MTB-FTP021_8J7On the marketCertificate health across this manufacturer's portfolio.
CSQ0026240724SupplementedNotified 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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