Organization name

NIPRO CORPORATION

SRN

JP-MF-000026759

Manufacturer status

Active

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

• Do not re-use
• Do not use if package is damaged
• Contains hazardous substances

Primary placement in Germany; available across 22 countries total.

Trade name

DENTAL NEEDLE

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.

04987458005596

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.

49684200TDG1031JV

Reference / catalog number

7710

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

No additional information URL provided by the manufacturer.

Clinical sizes

• 30G
• 25 MU50

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

• 04987458005596× 1 unitBase unit
  • 14987458005593× 100 units
    • 34987458005597× 100 units

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

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

• A010601CARPULE NEEDLES

• Class IIa medical devices in EUDAMED

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