- Role
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CN-MF-0000107107-ACL Rapid Test Dipstick is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Hangzhou Alltest Biotech.Co.,Ltd.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 30, 2026
B-DACL-1015FPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-DACL-1015F
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
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.
Primary placement in Belgium; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | 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-DACL-1015FBasic 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-DACL-1015FDACL-101UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102090299TOXICOLOGY - OTHERCertificate health across this manufacturer's portfolio.
V76 095123 0019SupplementedNotified 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.
V76 095123 0020SupplementedNotified 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.
EU-TDA-FI-51326-800081-2026IssuedNotified 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.
EU-QMS-FI-08820-800081-2026IssuedNotified 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.
EU-QMS-FI-08820-800081-2026IssuedNotified 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.
CN26/00001622IssuedNotified 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-INCP-402H8On the market7-ACL Rapid Test CassetteB-DACL-1025HOn the market7-ACL Rapid Test CassetteB-DACL-R102UZOn the market7-ACL Rapid Test PanelB-DACL-1145QOn the marketABP Rapid Test CassetteB-DABP-H902V6On the marketABP Rapid Test CassetteB-DABP-1026GOn the marketNo certificate specifically references this device's Basic UDI-DI.