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EUDAMED last updated this device on Aug 15, 2023
4015672112835DC30-E-AC (C30-2-E) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by OMRON Healthcare Co., Ltd.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04015672112834C30-2-EJP-MF-000007213(01)04015672112834
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Czechia; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Jan 1, 2023 | Jan 1, 2028 |
| Belgium | Jan 1, 2023 | Jan 1, 2028 |
| Germany | Jan 1, 2023 | Jan 1, 2028 |
| Spain | Jan 1, 2023 | Jan 1, 2028 |
| Croatia | Jan 1, 2023 | Jan 1, 2028 |
| Hungary | Jan 1, 2023 | Jan 1, 2028 |
| Lithuania | Jan 1, 2023 | Jan 1, 2028 |
| Portugal | Jan 1, 2023 | Jan 1, 2028 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z129080VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - HARDWARE ACCESSORIESPrimary 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 →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.
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 →Certificate health across this manufacturer's portfolio.
HZ 2102042-1ReissuedHZ 2102042-1SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →4015672104054UOn the marketBody Comp Monitor BF511 Turq (HBF-511T-E)4015672104064WOn the marketC30-2-UK (C30-UK-AC)4015672112845FOn the marketChild Mask (NEB-MSMP-E)40156721023953On the marketChild Mask(SEBS)set (NEB-MSSS-E)4015672102414NOn the marketCM (HEM-CR24-RU)4015672105585NOn the marketNo certificate specifically references this device's Basic UDI-DI.