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EUDAMED last updated this device on Dec 13, 2025
0850376007808EMR Bore Drape w/Extension (IMRIS) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by ClearPoint Neuro, Inc.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00850376007826NGS-PD-04-E(01)00850376007826
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12100685STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLESUS-MF-000010239The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
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.
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 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.0850376007488JOn the marketIRRAflow Drainage Collection System086864300047CZOn the marketMR Patient Drape (IMRIS)0850376007808EOn the marketMR Neuro Drape Tapered (Siemens/Philips)-Long0850376007808EOn the marketMR Neuro Drape Tapered w/Extension (GE)-Long0850376007808EOn the marketSMARTFrame Accessory Kit, 4 Fr - EuropeB-00850359007515On the marketNo certificate specifically references this device's Basic UDI-DI.