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EUDAMED last updated this device on Mar 19, 2026
471081008NNH97YIPPB Circuit, 150cm 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.
04710810115134AB01241 packaging level registered — each level carries its own UDI-DI.
04710810115134× 1 unitBase unit44710810115132× 15 units(01)04710810115134
European Medical Device Nomenclature — the EU product classification assigned to this device.
R020106IPPB CIRCUITS1 warning recorded — scroll inside the panel to see all entries.
"1. The product is for use by trained medical personnel and before the marked expiration date. 2. Read and fully understand the instructions before use. 3. Inspect all parts to ensure they are clear and free of obstructions or foreign material before use. 4. Obstruction or leakage of the device can result in serious injury or death. 5. Patient should be constantly monitored whenever this device is in use. 6. Use test lung to check the function of the circuit and ventilator before connection to patient. 7. Do not administer oxygen in the presence of fire, spark or open flame. 8. Do not use in a toxic environment. 9. The single patient use circuit should not intended to be used on more than one patient. 10. This device has not been tested for use during Magnetic Resonance Imaging (MRI). 11. The use of the device during MRI procedures may result in the failure of the device, blurring of the image, or misinterpretation of the image."
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.
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