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EUDAMED last updated this device on Feb 27, 2026
B-GAHCG-101d-1TKCHCG Pregnancy Rapid Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by Zhejiang Orient Gene Biotech Co., Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-GAHCG-101d-1TKCGAHCG-101d-1TD-GAHCG-101d-1TKC
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160302HCG - RT & POC3 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW007CN-MF-000017965No.V1 092305 0002Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
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.
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.
V10 092305 0004SupplementedCR-04-1249-874-25SupplementedCR-04-1249-875-25IssuedNotified 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 →B-GAHCG-101b-1TJWOn the marketHCG Pregnancy Rapid TestB-GAHCG-102a-2TK5On the marketHCG Pregnancy Rapid TestB-GAHCG-101d-5TKQOn the marketHCG Pregnancy Rapid TestB-GAHCG-101d-2TKFOn the marketHCG Pregnancy Rapid TestB-GAHCG-101a-2TJSOn the marketHCG Pregnancy Rapid TestB-GAHCG-103d-2TL5On the marketNo certificate specifically references this device's Basic UDI-DI.