Organization name

MANI, INC.

SRN

JP-MF-000017860

Manufacturer status

Active

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

1 warning recorded — scroll inside the panel to see all entries.

• Do not use if package is damaged

Primary placement in Germany; available across 32 countries total.

Trade name

MANI K-FILES - 21mm #45-80

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.

04546951501877

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.

4546951000001Z9

Reference / catalog number

-

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

6

Additional product description

#45 *1Pc, #50 *1Pc, #55 *1Pc, #60 *1Pc, #70 *1Pc, #80 *1PC

Additional information URL

https://www.mani.co.jp/en/product/eifus/

Clinical sizes

• 21 MU50

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

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

• L159004ENDODONTIC RASPS AND FILES, REUSABLE

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.