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EUDAMED last updated this device on Aug 21, 2026
3701089512B1602PE0JGANATOMIC Tibial Augment Size 6/7/8 Thickness 15 mm RL/LM is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by AMPLITUDE. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
FR-MF-000003453(01)03701089508056
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
7 warnings recorded — scroll inside the panel to see all entries.
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 France; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Germany | — | Still on market |
| Spain | — | Still on market |
| Slovenia | — | 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.
03701089508056Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
3701089512B1602PE0JG1-0210656UDI 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.
P09098001KNEE PROSTHESES AUGMENTSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →3701089512B1602PE0JGOn the marketANATOMIC Tibial Augment Size 6/7/8 Thickness 10 mm RL/LM3701089512B1602PE0JGOn the marketANATOMIC Tibial Augment Size 6/7/8 Thickness 10 mm RM/LL3701089512B1602PE0JGOn the marketANATOMIC Tibial Augment Size 6/7/8 Thickness 15 mm RM/LL3701089512B1602PE0JGOn the marketANATOMIC Tibial Augment Size 6/7/8 Thickness 5 mm3701089512B1602PE0JGOn the marketBroach handle extraction shaft3701089521R060107PEmb0HWOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
MDR 822547SupplementedNotified 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 →