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EUDAMED last updated this device on May 14, 2026
B-06970522646199Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Thyroglobuline (TG) Assay Kit (Chemiluminescent Immunoassay) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Sichuan Orienter Biotechnology Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →06970522646199Basic 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 →B-06970522646199CA2301UDI 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 →(01)06970522646199
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01020408THYROGLOBULIN1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Still on market |
CN-MF-000003026No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.B-06970522642788On the marketCarbohydrate Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Immunoassay)B-06970522645505On the market2×50 test/box Calibrator:0.5mL×2B-06970522641651On the market25-Hydroxy Vitamin D (25-OH VD) Assay Kit (Chemiluminescent Immunoassay)B-06970522649176On the market3,5,3´-Triiodothyronine (T3) Assay Kit (Chemiluminescent Immunoassay)B-06970522648872On the market