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CN-MF-000012364OPERO PLUS VELCRO TAPE is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Cobes Industries(Hefei) Co.,Ltd. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 20, 2026
69562886NB0001M2Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06956288682268
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
4 warnings recorded — scroll inside the panel to see all entries.
CW001CW009CW007CW032Sterile
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 19 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Estonia | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Italy | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Slovenia | — | 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.
06956288682268Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
69562886NB0001M2W031030900UDI 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.
T030199COVERS, INSTRUMENTS AND EQUIPMENT - OTHERNo certificate specifically references this device's Basic UDI-DI.
69562886YA0002R8On the marketOPERO PLUS STOCKINETTE + ADHESIVE TAPE69562886YA0002R8On the marketOPERO PLUS TUBE HOLDER69562886NB0001M2On the marketOPERO SET LARYNGOLOGICAL SET RED MAYO STAND COVER69562886IA0002JQOn the marketOPERO SET UNIVERSAL SET WITH "U" DRAPE69562886MA0004LGOn the marketOPERO SET UNIVERSAL SET WITH "U" DRAPE RED MAYO STAND COVER69562886MA0004LGOn the marketNo 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.