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FR-MF-000000819ADJUSTABLE VALGUS DEVICE is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by FOURNITURES HOSPITALIERES INDUSTRIE. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Aug 20, 2026
3661489GENOUCIRMREPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03661489646850
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 10 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Cyprus | — | Still on market |
| Germany | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | 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.
03661489646850Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
3661489GENOUCIRMRE264685UDI 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.
L091199ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHERNo certificate specifically references this device's Basic UDI-DI.
3661489GENOUCIRMREOn the marketACL FEMORAL GUIDE POINT TO POINT3661489LIGTLSCIRMJZOn the marketACL FEMUR HOOK A.L. POINT TO POINT3661489LIGTLSCIRMJZOn the marketAL FEMORAL HOOK - ACL PT TO PT3661489LIGTLSCIRMJZOn the marketALL AIMER ARTHROSCOPIC LEFT OFFSET H636614892415ALLCIRMP6On the marketALL AIMER ARTHROSCOPIC RIGHT OFFSET H636614892415ALLCIRMP6On the marketCertificate health across this manufacturer's portfolio.
40595IssuedNotified 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.
40599IssuedNotified 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.
40594IssuedNotified 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.
40362AmendedNotified 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.
40417AmendedNotified 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.
38944SupplementedNotified 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.
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