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FR-MF-000001538URGO Corn Protective is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Laboratoires URGO HEALTHCARE. Placed on the EU market in Bulgaria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jan 24, 2024
3664492LUHUS0019PNPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03664492001388
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning 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 Bulgaria; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Italy | — | Still on market |
| Lithuania | — | Still on market |
| Latvia | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | 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.
03664492001388Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
3664492LUHUS0019PN3664492001388UDI 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.
M0499SPECIAL DRESSINGS - OTHERCertificate health across this manufacturer's portfolio.
10000452411-PA-NoMA-FRAIssuedNotified 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 →B-3664492LUHUS0023PDS6On the marketURGO BURNS, SUPERFICIAL WOUNDS, sterile tulle;B-3664492LUHUS0029PRTYOn the marketURGO Calluses3664492LUHUS0051PJOn the marketURGO Corns & Soft corns3664492LUHUS0050PGOn the marketURGO Damaged nails by Mycosis and mild traumatism3664492LUHUS0059Q2On the marketURGO DISCREET3664492LUHUS0027PMOn the marketNo certificate specifically references this device's Basic UDI-DI.