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EUDAMED last updated this device on May 11, 2022
6438129B0040H6evercare® XP warm-up jacket, medium sleeve M is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by OneMed Group Oy. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
FI-MF-000000642(01)06438129123234
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 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 | May 27, 2021 | Still on market |
| Denmark | May 27, 2021 | Still on market |
| Estonia | May 27, 2021 | Still on market |
| Finland | May 27, 2021 | Still on market |
| Lithuania | May 27, 2021 | Still on market |
| Latvia | May 27, 2021 | Still on market |
| Norway | May 27, 2021 | 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.
06438129123234Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
6438129B0040H6260012UDI 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.
T0299PROTECTION DRAPES AND GARMENTS - 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 →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 →No certificate specifically references this device's Basic UDI-DI.
6438129B0040H6On the marketevercare® XP warm-up jacket, long sleeve XXXL6438129B0040H6On the marketevercare® XP warm-up jacket, medium sleeve L6438129B0040H6On the marketevercare® XP warm-up jacket, medium sleeve S6438129B0040H6On the marketevercare® XP warm-up jacket, medium sleeve XL6438129B0040H6On the marketevercare® XP warm-up jacket, medium sleeve XS6438129B0040H6On the market