Organization name

F. Bosch International Limited

SRN

HK-MF-000029001

Manufacturer status

Active

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

4 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Do not re-use
• EUH 208 – Contains (name of sensitising substance). May produce an allergic reaction.

  latex

• H317 – May cause an allergic skin reaction.

Primary placement in EL; available across 32 countries total.

Trade name

F. Bosch Latex White Gloves Powdered M

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.

04897146981135

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.

489714698FBGLVELATEXQX

Reference / catalog number

FBGLVE-1023

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 I

Applicable legislation

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

Status

On the market

Quantity

100

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Size M

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

• 04897146981135× 100 unitsBase unit
  • 04897146981333× 10 units

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

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

• T010201LATEX EXAMINATION / TREATMENT GLOVES

• Class I medical devices in EUDAMED