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EUDAMED last updated this device on Mar 15, 2022
471096971TCF01II01012AFrazier Suction Tip is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Pacific Hospital Supply Co., Ltd.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04719873431793P022562 packaging levels registered — each level carries its own UDI-DI.
04719873431793× 1 unitBase unit14719873431790× 50 units24719873431797× 6 units(01)04719873431793
European Medical Device Nomenclature — the EU product classification assigned to this device.
A06010103CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE4 warnings recorded — scroll inside the panel to see all entries.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Aug 27, 2021 | Aug 27, 2026 |
TW-MF-000007247The 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 →B-04719879052091On the marketDisposable Syringe (Kit)B-04719879052053On the marketenteral feeding bag471096971TCF34II01025QOn the marketFree Trachea Closed Suction Set471096971TCF17II010163On the marketHigh-Flow Irrigation/Suction Set471096971TCF13II01013XOn the marketHigh-Flow Irrigation/Suction Set471096971TCF13II01013XOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
10000513720-PA-NoMA-TWNIssued10000440013-PA-NoMA-TWNIssuedNotified 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 →Notified 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 →