- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 28, 2022
5944757400000033NSCOVERX2Cearceaf u.f., cu elastic la capete,100 x 200 cm, Spunbond bistratificat is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Coramed Medizinische Produkte SRL. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
059447574016193321020RO-MF-000018007Primary 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.
(01)05944757401619
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 Romania; available across 1 country total.
Placed on the market in Romania; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
T030102COVER SHEATHS, INSTRUMENTS AND EQUIPMENTSPrimary 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 →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.594475740044NSEQUIPMENT3HOn the marketCearceaf pilota SMS594475740044NSEQUIPMENT3HOn the marketCearceaf u.f. cu elastic la capete,SMS, 100 x 210 cm5944757400000033NSCOVERX2On the marketCearceaf uf ,cu elastic la capete,120x200 cm5944757400000033NSCOVERX2On the marketCearceaf uf 200 x120 cm5944757400000033NSCOVERX2On the marketCearceaf uf cu elastic la capete, 150 x 210cm5944757400000033NSCOVERX2On the market