- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Aug 31, 2026
B-16974969799804Control For Pepsin is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Chongqing iSIA BIO-Technology Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
16974969799804039Z(01)16974969799804
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101050201ENZYME CONTROLS1 warning recorded — scroll inside the panel to see all entries.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
CN-MF-000003364Sterile
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-16974969791662On the marketControl For Osteocalcin (OC)B-16974969799286On the marketControl For Parathyroid Hormone (PTH)B-16974969799279On the marketControl For Pepsinogen (PGI/PGII)B-16974969799118On the marketControl For Procalcitonin (PCT)B-16974969799156On the marketControl For ProgesteroneB-16974969799576On the marketNo 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.