- Role
- Country
- Date of registration
- Address
BE-MF-000000691No 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.Gammex PI Plus Glove-in-Glove System is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Ansell Healthcare Europe NV. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Mar 6, 2023
5414566GPIPLGIG340088VPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)15414566822655
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 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 Belgium; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Jan 5, 2023 | Jan 4, 2028 |
| Austria | Jan 5, 2023 | Jan 4, 2028 |
| Bulgaria | Jan 5, 2023 | Jan 4, 2028 |
| Cyprus | Jan 5, 2023 | Jan 4, 2028 |
| Czechia | Jan 5, 2023 | Jan 4, 2028 |
| Germany | Jan 5, 2023 | Jan 4, 2028 |
| Denmark | Jan 5, 2023 | Jan 4, 2028 |
| Estonia | Jan 5, 2023 | Jan 4, 2028 |
| EL | Jan 5, 2023 | Jan 4, 2028 |
| Spain | Jan 5, 2023 | Jan 4, 2028 |
| Finland | Jan 5, 2023 | Jan 4, 2028 |
| France | Jan 5, 2023 | Jan 4, 2028 |
| Croatia | Jan 5, 2023 | Jan 4, 2028 |
| Hungary | Jan 5, 2023 | Jan 4, 2028 |
| Ireland | Jan 5, 2023 | Jan 4, 2028 |
| Iceland | Jan 5, 2023 | Jan 4, 2028 |
| Italy | Jan 5, 2023 | Jan 4, 2028 |
| Liechtenstein | Jan 5, 2023 | Jan 4, 2028 |
| Lithuania | Jan 5, 2023 | Jan 4, 2028 |
| Luxembourg | Jan 5, 2023 | Jan 4, 2028 |
| Latvia | Jan 5, 2023 | Jan 4, 2028 |
| Malta | Jan 5, 2023 | Jan 4, 2028 |
| Netherlands | Jan 5, 2023 | Jan 4, 2028 |
| Norway | Jan 5, 2023 | Jan 4, 2028 |
| Poland | Jan 5, 2023 | Jan 4, 2028 |
| Portugal | Jan 5, 2023 | Jan 4, 2028 |
| Romania | Jan 5, 2023 | Jan 4, 2028 |
| Sweden | Jan 5, 2023 | Jan 4, 2028 |
| Slovenia | Jan 5, 2023 | Jan 4, 2028 |
| Slovakia | Jan 5, 2023 | Jan 4, 2028 |
| Türkiye | Jan 5, 2023 | Jan 4, 2028 |
| XI | Jan 5, 2023 | Jan 4, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
15414566822655Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5414566GPIPLGIG340088V340082065 6.5UDI 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.
2 packaging levels registered — each level carries its own UDI-DI.
15414566822655× 1 unitBase unit25414566822652× 50 units35414566822659× 4 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
T01010203POLYISOPREN SURGICAL GLOVES5414566GPIHYBM3400KROn the marketGAMMEX PI Hybrid Micro5414566GPIHYBM3400KROn the marketGAMMEX PI Hybrid Micro5414566GPIHYBM3400KROn the marketGammex PI Plus Glove-in-Glove System5414566GPIPLGIG340088VOn the marketGammex PI Plus Glove-in-Glove System5414566GPIPLGIG340088VOn the marketGammex PI Plus Glove-in-Glove System5414566GPIPLGIG340088VOn the marketNo certificate specifically references this device's Basic UDI-DI.