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FI-MF-000000642evercare® inLine GRAVITY SET, VENTED, FILTERSTOP, PVC Free, 220 cm is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by OneMed Group Oy. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Mar 18, 2026
6438129B0024H8Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06438129002041
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
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.
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 Sweden; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Mar 6, 2026 | Still on market |
| Denmark | Mar 6, 2026 | Still on market |
| Estonia | Mar 6, 2026 | Still on market |
| Finland | Mar 6, 2026 | Still on market |
| Lithuania | Mar 6, 2026 | Still on market |
| Latvia | Mar 6, 2026 | Still on market |
| Norway | Mar 6, 2026 | 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.
06438129002041Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
6438129B0024H810701UDI 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.
1 packaging level registered — each level carries its own UDI-DI.
06438129002041× 1 unitBase unit06438129002058× 80 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
A03010101INFUSION CONTROLLERS WITH OR W/O AIR INLET6438129B0024H8On the marketevercare® inLine GRAVITY SET, VENTED, FILTERSTOP, NEEDLE FREE CONNECTOR, PVC Free, 180 cm6438129B0024H8On the marketevercare® inLine GRAVITY SET, VENTED, FILTERSTOP, PVC Free, 180 cm6438129B0024H8On the marketevercare® inLine GRAVITY SET, VENTED, FILTERSTOP, PVC Free, 320 cm6438129B0024H8On the marketevercare® inLine GRAVITY SET, VENTED, NEEDLE FREE CONNECTOR, PVC Free, 180 cm6438129B0024H8On the marketevercare® inLine GRAVITY SET, VENTED, PVC Free, 180 cm6438129B0024H8On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
10000510541-PA-NoMA-DNKIssued10000510540-PA-NoMA-DNKIssuedNotified 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 →