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EUDAMED last updated this device on Jun 26, 2026
803377232HMC-SET-ETO-Z8DP150 Hemoconcentrator set DHF - 1.5 SQM is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Medica S.p.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
IT-MF-000025691(01)08056992330221
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
6 warnings recorded — scroll inside the panel to see all entries.
CW011CW010CW001CW009CW007CW032Sterile
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 9 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jun 1, 2023 | Still on market |
| Austria | Jun 1, 2023 | Still on market |
| Germany | Jun 1, 2023 | Still on market |
| Spain | Jun 1, 2023 | Still on market |
| France | Jun 1, 2023 | Still on market |
| Ireland | Jun 1, 2023 | Still on market |
| Netherlands | Jun 1, 2023 | Still on market |
| Portugal | Jun 1, 2023 | Still on market |
| XI | Jun 1, 2023 | 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.
08056992330221Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
803377232HMC-SET-ETO-Z8EU80346MUDI 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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
C03010101EXTRACORPOREAL CIRCULATION CIRCUITSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →803377232HMC-SET-ETO-Z8On the marketDP 230 Hemoconcentrator set803377232HMC-SET-ETO-Z8On the marketDP 60 Hemoconcentrator set803377232HMC-SET-ETO-Z8On the marketEmoconcentratore D025 / D025 Hemoconcentrator803377232HMC-RAY-KYOn the marketEmoconcentratore D050 / D050 Hemoconcentrator803377232HMC-RAY-KYOn the marketEmoconcentratore D050 con 2 valvole e 3 vie / D050 Hemoconcentrator with n°2 valves and 3 ways803377232HMC-RAY-KYOn 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.No certificate specifically references this device's Basic UDI-DI.