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EUDAMED last updated this device on Mar 25, 2026
B-08058964724113KeyFix Direct Access Needle is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by G21 S.R.L.. Placed on the EU market in Portugal. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
IT-MF-000030085MED 28029_1(01)08058964724113
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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 Portugal; available across 11 countries total.
| Country | On market since | Until |
|---|---|---|
| PortugalPrimary placement | Jul 22, 2015 | Still on market |
| Austria | Feb 15, 2022 | Still on market |
| Bulgaria | May 30, 2019 | Still on market |
| Cyprus | Jan 10, 2018 | Still on market |
| Germany | May 7, 2021 | Still on market |
| EL | Sep 29, 2025 | Still on market |
| Spain | Mar 9, 2018 | Still on market |
| Italy | Jul 19, 2017 | Still on market |
| Lithuania | Sep 7, 2018 | Still on market |
| Netherlands | Feb 15, 2022 | Still on market |
| Poland | Aug 28, 2020 | 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.
08058964724113Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-08058964724113900103UDI 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.
K010302MINIMALLY INVASIVE SPINAL SURGERY INSTRUMENTS, SINGLE-USEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
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No 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.