- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jul 18, 2023
506047191ASPFA3-Set is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Anaesthetic Medical Systems Ltd. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
050604719100297300A(01)05060471910029
European Medical Device Nomenclature — the EU product classification assigned to this device.
A070103INFUSION TUBING ADAPTERS AND CONNECTORS3 warnings recorded — scroll inside the panel to see all entries.
Do not use on a patient with known hypersensitivity to silicone or plastic materials. Please contact the manufacturer for advice if in doubt. If not used appropriately according to the instructions above, there is a risk of: • Occlusion or backflow causing under-infusion or over-infusion • Syphoning from pump or syringe causing accidental overdose • Patient drug reactions from premature or inappropriate mixing • Patient allergic reaction if hypersensitive to materials • Embolism from admission of air into administration lines
GB-MF-000016544The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in XI; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| XIPrimary placement | Jan 1, 2012 | Still on market |
| EL | Jan 1, 2012 | Still on market |
| Ireland | Jan 1, 2012 | Still on market |
| Norway | Jan 1, 2012 | Still on market |
| Sweden | Jan 1, 2012 | Still on market |
| Türkiye | Jan 1, 2012 | Still on market |
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.
28620126993IssuedNotified 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 →