- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Sep 1, 2026
89042553MHC_ROB66SGTIBIA SCREW (Ø4)- Instruments for MISSO® Orthopedic Robotic System is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Meril Healthcare Pvt. Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08904255372092MCAT-001IN-MF-0000061062975-MED-2607601(01)08904255372092
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability Pathological skeletal conditions Patients with systemic illness Poor skin or bone stock condition Severe femoral or tibial deformity Patients with any metallic object in the operative leg or counter-operative leg Judged to be unsuitable for the surgery at the discretion of the medical doctor
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 Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12130480STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIESPrimary 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 →89042553MHC_ROB66SGOn the marketSTERILE ROBOT DRAPE- Accessories (Consumables) for MISSO® Orthopedic Robotic System89042553MHC_ROB66SGOn the marketTIBIA MARKER FIXTURE- Instruments for MISSO® Orthopedic Robotic System89042553MHC_ROB66SGOn the marketTIBIA TRACKING MARKER- Instruments for MISSO® Orthopedic Robotic System89042553MHC_ROB66SGOn the marketUNIVERSAL ARM TRACKING MARKER- Instruments for MISSO® Orthopedic Robotic System89042553MHC_ROB66SGOn the marketUSB DRIVE-Accessories for MISSO® Orthopedic Robotic System89042553MHC_ROB66SGOn the marketCertificate health across this manufacturer's portfolio.
2975-MED-2607601Amended2975-MED-2607601IssuedNotified 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 →Notified 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 →