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EUDAMED last updated this device on Mar 19, 2026
471081008NNG17DBubble PAP Valve is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by GaleMed Corporation. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04710810117466AN0018 1 packaging level registered — each level carries its own UDI-DI.
04710810117466× 1 unitBase unit44710810117464× 12 units(01)04710810117466
European Medical Device Nomenclature — the EU product classification assigned to this device.
R02010401CPAP CIRCUITS1 warning recorded — scroll inside the panel to see all entries.
"• PAP therapy may have an adverse effect on cardiopulmonary status. • Always monitor, maintain and verify PAP level with a manometer that measures proximal airway pressure. • Read and understand the contents of this insert and demonstrate proficiency in the application of this device prior to use. • The product is intended to be used by qualified medical personnel trained in pulmonary ventilation and advanced cardiac life-support techniques. • This Bubble CPAP system has not been tested for use during Magnetic Resonance Imaging (MRI). However, this device does not contain any ferrous material. The use of the Bubble CPAP system during MRI procedures may result in the failure of the device, blurring of the image, or misinterpretation of the image. • Do not attempt to disassemble the Valve as it will damage the components. • Single-patient use do not reuse, soak, rinse, or sterilize the Bubble CPAP system as these procedures may leave harmful residues and may impede the function of the device."
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | May 9, 2023 | May 8, 2028 |
TW-MF-000022411The 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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →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 2100418-1IssuedNotified 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.
No certificate specifically references this device's Basic UDI-DI.
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