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EUDAMED last updated this device on Dec 13, 2024
471081008NNE47DLVN Nebulizer Kit 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.
04710810106743AD0099(01)04710810106743
European Medical Device Nomenclature — the EU product classification assigned to this device.
R03010304AEROSOL THERAPY KITS1 warning recorded — scroll inside the panel to see all entries.
" Aerosol Mask: 1. The product is for single patient use, the maximum recommended is 7 days. 2. Please confirm the integrity of all parts and packaging before use. If there is any doubt or damage, please do not use this product. 3. This instruction is only a general indication, and it still needs to be used by professional medical personnel or someone trained by medical personnel. 4. Dispose of in accordance with the local medical waste disposal regulations. 5. The device is for single use only. Any modification, rework, or sterilization will result in device malfunction or failure and also increase the risk of cross-infection of disease. 6. Discontinue use if discomfort occurs, and consult your physician. Nebulizer: 1. Liquid can have distinct side effects and interactions in a nebulized form. Make sure to consult with your doctor and follow their instructions carefully before applying a nebulized liquid, even if you’re already using the same liquid via different routes. 2. The use of facemasks should be avoided when specific liquid is used since they can cause side effects on the skin of the face and eyes. 3. To avoid the contamination of the nebulizer with bacteria, the nebulizer cup, and the interface should be rinsed and dried after using, and disinfected once or twice a week according to the manufacturer’s instructions."
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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.