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EUDAMED last updated this device on Sep 5, 2022
8431785UDI-DI-076TCOLECTOR ORINA 24 HORAS VACÍO UNIT. APOSAN is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by ENVASES FARMACÉUTICOS, S.A.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0847000198601672W1 packaging level registered — each level carries its own UDI-DI.
08470001986016× 1 unitBase unit08431785001777× 48 units(01)08470001986016
European Medical Device Nomenclature — the EU product classification assigned to this device.
W050301029099SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHERES-MF-000000902The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | May 11, 2020 | 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.
8431785UDI-DI-086VOn the marketCOLECTOR ORINA 24 HORAS UNIT.ENFA8431785UDI-DI-086VOn the marketCOLECTOR ORINA 24 HORAS UNIT.PROBENE8431785UDI-DI-086VOn the marketCONTENEDOR CON ESPÁTULA ALVITA8431785UDI-DI-056POn the marketCONTENEDOR ORINA 24 H. 2 L.8431785UDI-DI-086VOn the marketCuña sanitaria APOSÁN8431785UDI-DI-016FOn 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.