- Organization name
- UDI-DI code
- Reference / catalog number
HU-MF-000004227Threaded stem is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Medimetál Gyógyászati Termékeket Gyártó és Forgalmazó Kft.. Placed on the EU market in Hungary. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 27, 2024
59965960000000000000001J7Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05996596294037
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 Hungary; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| HungaryPrimary placement | May 26, 2021 | Still on market |
| Bulgaria | May 26, 2021 | Still on market |
| EL | May 26, 2021 | Still on market |
| Latvia | May 26, 2021 | Still on market |
| Romania | May 26, 2021 | Still on market |
| Slovakia | May 26, 2021 | 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.
05996596294037Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
59965960000000000000001J794300-00500UDI 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.
L0999ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER59965960000000000000006JHOn the marketThreaded stem59965960000000000000004JDOn the marketThreaded stem59965960000000000000001J7On the marketThreaded stem (assembled)59965960000000000000004JDOn the marketThreaded stem (assembled)59965960000000000000004JDOn the marketThreaded stem (Z light blade)59965960000000000000004JDOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HZ 1400760-1SupplementedNotified 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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