- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Aug 10, 2026
B-06933289858144SmarLumi is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Guangzhou Wondfo Biotech Co., Ltd.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06933289858144W492P0004(01)06933289858144
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102069001GASTRINPrimary placement in Romania; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | Apr 20, 2025 | Dec 31, 2030 |
CN-MF-000000689Sterile
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 →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 →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
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 →Certificate health across this manufacturer's portfolio.
V76 058008 0051IssuedV76 058008 0050IssuedV76 058008 0045SupplementedV76 058008 0046SupplementedV76 058008 0048IssuedNotified 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 →Notified 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 →Notified 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 →Notified 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 →Notified 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 →No certificate specifically references this device's Basic UDI-DI.