- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 21, 2026
B-GBMDP-102aY9One Step 3,4-Methylenedioxypyrovalerone Test Cassette (Urine) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhejiang Orient Gene Biotech Co., Ltd. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-GBMDP-102aY9GBMDP-102aCN-MF-000017965D-GBMDP-102aY9
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
1 warning recorded — scroll inside the panel to see all entries.
CW032Sterile
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.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102090199DRUGS OF ABUSE - 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 →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 →No certificate specifically references this device's Basic UDI-DI.
69509960N3002DEEOn the marketNucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)B-06950996004473On the marketNucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)B-06950996004480On the marketOne Step 3,4-Methylenedioxypyrovalerone Test Strip (Urine)B-GBMDP-101aY6On the marketOne Step 6-MAM Test Cassette (Urine)B-GBMAM-S102a2AOn the marketOne Step 6-MAM Test Strip (Urine)B-GBMAM-S101a27On the marketCertificate health across this manufacturer's portfolio.
6188440TD11IssuedNotified 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.
6188440CE01SupplementedNotified 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.
V10 092305 0004SupplementedNotified 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.
6188440TD10IssuedNotified 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.
6188440TD09IssuedNotified 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.
6188440TD08IssuedNotified 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 →