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EUDAMED last updated this device on Jan 26, 2022
081544002TD007URPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Senhance Connect is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Asensus Surgical Italia S.r.l.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →00815440022228Basic 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 →081544002TD007URX9007741UDI 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 →(01)00815440022228
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER3 warnings recorded — scroll inside the panel to see all entries.
CW010CW023CW007Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
IT-MF-000007964Certificate health across this manufacturer's portfolio.
ITH 1024597 1AmendedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →081544002TD006UPOn the marketAdapter, Passive Johan Grasper 15 mm Tip Ø 5 mm x 240 mm081544002TD006UPOn the marketMonopolar L-Hook Electrode Ø 5 mm x 240 mm081544002TD005UMOn the marketAdapter for new platform Right Angle Dissector, Long Ø 10mm x 410mm081544002TD006UPOn the marketAdapter, Allis Grasper Ø 5 mm x 240 mm081544002TD006UPOn the market