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EUDAMED last updated this device on Jun 9, 2023
B-16935238802403W050101010202 BLOOD COLLECTION, TUBES WITHOUT ADDITIVES OR SERUM SEPARATOR is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Chengdu Rich Science Industry Co., Ltd.. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
16935238802403803CN-MF-00002062215056726 001(01)16935238802403
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1.Single use only. They shall be disposed after use accordance to relevant regulations of different countries/regions. 2.This product is only used to collect, transfer, store and handle venous blood specimen in clinic test. After blood collection, it's forbidden to apply any part of treated blood specimen to human body. 3. It is forbidden to use syringe to collect blood and then inject it into the blood vessel in vacuum, which will increase the risk of pollution, at the same time, there are inaccurate quantity of blood collection, anticoagulant blood coagulation or clot, inaccurate proportion with additive, etc. Influence test results. 4. It is not recommended to collect blood tests from human transfusion tubes, which may interfere with the test results. 5. It’s not suggested to use C.D.RICH
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 Austria; available across 1 country total.
Placed on the market in Austria; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W050101010201BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATORPrimary 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.
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.