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CN-MF-000006019Infusion Sets for Single Use (B1-0Y2DSPZ1) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Jiangxi Hongda Medical Equipment Group Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 5, 2023
69207567GSYQ000199Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06920756726068
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Italy; available across 11 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | May 19, 2023 | May 19, 2059 |
| Cyprus | May 19, 2023 | May 19, 2059 |
| Czechia | May 19, 2023 | May 19, 2059 |
| Germany | May 19, 2023 | May 19, 2059 |
| Denmark | May 19, 2023 | May 19, 2059 |
| EL | May 19, 2023 | May 19, 2059 |
| Hungary | May 19, 2023 | May 19, 2059 |
| Lithuania | May 19, 2023 | May 19, 2059 |
| Poland | May 19, 2023 | May 19, 2059 |
| Romania | May 19, 2023 | May 19, 2059 |
| Türkiye | May 19, 2023 | May 19, 2059 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06920756726068Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
69207567GSYQ000199B111SUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
2 packaging levels registered — each level carries its own UDI-DI.
06920756726068× 1 unitBase unit16920756726065× 25 units26920756726062× 20 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
A03010101INFUSION CONTROLLERS WITH OR W/O AIR INLETA03010102INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)A03010103INFUSION CONTROLLERS WITH FLOW REGULATORNo certificate specifically references this device's Basic UDI-DI.
69207567GSYQ00029BOn the marketInfusion sets for single use69207567GSYQ000199On the marketInfusion sets for single use69207567GSYQ00039DOn the marketInfusion Sets for Single Use (B1-0Y2DSTN)69207567GSYQ000199On the marketInfusion Sets for Single Use (B1-0Y2DSTZ1)69207567GSYQ000199On the marketInfusion Sets for Single Use (B1-0Y2DSTZ1)69207567GSYQ000199On 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.