Organization name

Ansell Healthcare Europe NV

SRN

BE-MF-000000691

Manufacturer status

Active

Primary placement in Belgium; available across 32 countries total.

Trade name

Gammex PI Hybrid

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

15414566630854

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

5414566GEPIHYB340UL

Reference / catalog number

340063085 8.5

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.ansell.com/gb/en/products/gammex-pi-hybrid

Clinical sizes

No clinical sizes registered for this device.

2 packaging levels registered — each level carries its own UDI-DI.

• 15414566630854× 1 unitBase unit
  • 25414566630851× 50 units
    • 35414566630858× 4 units

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• T01010299SYNTHETIC SURGICAL GLOVES - OTHER

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.