- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Sep 19, 2022
59026271kojce-premium87KOJEC PREMIUM is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Motherhood Sp. z o.o.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05901323928123101PL-MF-000027049(01)05901323928123
The 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.
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 Poland; available across 9 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Finland | — | Still on market |
| Hungary | — | Still on market |
| Lithuania | — | Still on market |
| Latvia | — | Still on market |
| Netherlands | — | Still on market |
| Slovakia | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
V080302PATIENT POSITIONING MEDICAL CUSHIONSPrimary 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 →59026271p.baweln195x160HAOn the marketALL-COTTON WATERPROOF PAD 195X9059026271p.baweln.195x90AWOn the marketALL-COTTON WATERPROOF PAD 90X6559026271p.baweln.90x65NKOn the marketKOJEC STANDARD59026271kojec_standardB4On the marketMEDICAL SLEEPY-C59026271kojce-medicalCTVOn the marketNURSING SUPPORT PILLOW59026271fasolki-stand.LGOn the marketNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.