- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Apr 24, 2026
B-06970341681081Parathyroid Hormone (Electrochemiluminescence Immunoassay) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Shenzhen Lifotronic Technology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000005654(01)06970341681081
1 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.
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 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | 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.
06970341681081Basic 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-06970341681081693020UDI 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.
W0102060312PARATHYROID HORMONE INTACTPrimary 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 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.No certificate specifically references this device's Basic UDI-DI.
B-0320515304W3On the marketPAPP-A (eCLIA)B-0320515302VXOn the marketParathyroid Hormone (Electrochemiluminescence Immunoassay)B-06970341688127On the marketParathyroid Hormone (Electrochemiluminescence Immunoassay)B-06970341680671On the marketParathyroid Hormone (Electrochemiluminescence Immunoassay)B-06975984063157On the marketPCT STAT (eCLIA)B-06975984062990On the market