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EUDAMED last updated this device on May 24, 2025
++G2311400714012SAPOLITZER EAR SPECULUM is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by RAJ IMPEX. Placed on the EU market in Latvia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
L149004ENT SPECULUMS, REUSABLEPrimary placement in Latvia; available across 1 country total.
Placed on the market in Latvia; per-country availability dates not published.
PK-MF-000029068Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →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 →No certificate specifically references this device's Basic UDI-DI.
++G231DE10611067NHOn the marketPOINTED PROBE DOUBLE ENDED HANDLE 6MM,LENGHT170MM++G231DE7187222LOn the marketPOINTED PROBE DOUBLE ENDED HANDLE 6MM,LENGHT170MM++G231DE711717Z7On the marketPOSITIVE POSITIONER++G231DE1808FYOn the marketROOT FRAGMENT FORCEPS++G231DE076103Y8On the marketROSER-KONIG 16CM 19CM++G231DE12751276RPOn 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.