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EUDAMED last updated this device on Jun 12, 2026
42502737NIV50611s000000BCExtra-Spike® Plus, 5 µm, KP is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Fresenius Kabi AG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
DE-MF-000009273(01)04250273726367
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
5 warnings recorded — scroll inside the panel to see all entries.
CW011CW009CW001CW007CW010Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Czechia | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Slovakia | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04250273726367Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
42502737NIV50611s000000BC2902817UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
A0799ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
42502737NIV50611s000000BCOn the marketExtra-Spike® Chemo Plus, 5 µm, red42502737NIV50611s000000BCOn the marketExtra-Spike® Plus, 5 µm, blue42502737NIV50611s000000BCOn the marketExtra-Spike® Plus, green42502737NIV50611s000000BCOn the marketFreeflex® Transfer-Adapter steel/plastic42502737NIV50611s000000BCOn the marketFreeflex+ Transfer Adapter42502737NIV50611s000000BCOn the marketCertificate health across this manufacturer's portfolio.
G10 037258 0014SupplementedNotified 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 →