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EUDAMED last updated this device on Jul 28, 2026
6921756499990088XVMission Hb Hemoglobin Meter is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Acon Biotech (Hangzhou) Co., Ltd.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06921756471170C111-3031-201(01)06921756471170
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02010199CHEMISTRY INSTRUMENTS - OTHER1 warning recorded — scroll inside the panel to see all entries.
CN-MF-000006977The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Romania; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | — | Still on market |
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 →No certificate specifically references this device's Basic UDI-DI.
B-C111-2011QSOn the marketMission Cholesterol Test Device 3-in-1 Lipid PanelB-C131-2051S8On the marketMission Cholesterol Test Device 3-in-1 Lipid PanelB-C131-2041S5On the marketMission HDL High Density Lipoprotein Test DevicesB-C131-2031S2On the marketMission LancetsB-C121-3041RTOn the marketMission Plus Hb Hemoglobin Meter6921756499990099Y2On the marketCertificate health across this manufacturer's portfolio.
V76 042074 0046IssuedV76 042074 0044IssuedV76 042074 0045IssuedV76 042074 0043IssuedV13 042074 0039SupplementedNotified 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 →