- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Aug 1, 2023
69449040SHYQ-200BREF***YWReference electrode is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06944904024615040-000539-00CN-MF-000014156(01)06944904024615
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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Please see the IFU
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 Germany; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Dec 15, 2020 | Still on market |
| Netherlands | Dec 15, 2020 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101070199ELECTROLYTE ELECTRODES - 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 →Certificate health across this manufacturer's portfolio.
MDR 757840SupplementedCN26/00002236IssuedCN24/00005514IssuedCN24/00005514IssuedCN23/00003444SupplementedNotified 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 →69449040004JRBP********HUOn the marketRBP Control69449040004JRBP********HUOn the marketRed Blood Cell Folate Releasing Reagent69449040004L-RBCReagentVMOn the marketReference electrode69449040SHYQ-200CREF***ZFOn the marketRenin (CLIA)69449040004U-Renin*****J9On the marketRenin (CLIA)69449040AB74000095NOn the marketNo certificate specifically references this device's Basic UDI-DI.