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FR-MF-000000819TLS PRE-TENSIONED SCREW 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 May 29, 2026
3661489LIGTLSCIRMJZPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03661489560118
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 | Jan 10, 2025 | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Germany | — | Still on market |
| Spain | — | Still on market |
| Italy | — | Still on market |
| Luxembourg | — | Still on market |
| Netherlands | — | 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.
03661489560118Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
3661489LIGTLSCIRMJZ256011UDI 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 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.No certificate specifically references this device's Basic UDI-DI.
3661489LIGTLSCIRMJZOn the marketTLS PIN GUIDE CANNULA3661489LIGTLSCIRMJZOn the marketTLS PRE-TENSIONED ASSEMBLY3661489LIGTLSCIRMJZOn the marketTLS RETRO DRILL D123661489LIGTLSCIRMJZOn the marketTLS RETROREAMER D10-CANNULATED D2,5-V23661489LIGTLSCIRMJZOn the marketTLS RETROREAMER D11-CANNULATED D2,5-V23661489LIGTLSCIRMJZOn the market