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EUDAMED last updated this device on May 28, 2026
697022925GCE8XXEMCompressor Nebulizer Prolife PN Basic is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Globalcare Medical Technology Co., Ltd.. Placed on the EU market in Bulgaria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06970229251665929381 packaging level registered — each level carries its own UDI-DI.
06970229251665× 1 unitBase unit06970229251672× 4 unitsCN-MF-000033595(01)06970229251665
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning 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 Bulgaria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12159002AEROSOL EQUIPMENTPrimary 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.
G10 088855 0016IssuedNotified 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 →No certificate specifically references this device's Basic UDI-DI.
697022925GCE8XXEMOn the marketaponorm Basis697022925GCE6XXEBOn the marketCOMPRESSOR NEBULIZER AGU N3697022925GCE8XXEMOn the marketCOMPRESSOR NEBULIZER Prolife PN Compact697022925GCE8XXEMOn the marketDigital Blood Pressure Monitor Prolife PC2 Basic697022925GCE6XXEBOn the marketDigital Blood Pressure Monitor Prolife PC2 Basic AD697022925GCE6XXEBOn the market