Organization name

Joimax GmbH

SRN

DE-MF-000009201

Manufacturer status

Active

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

• Consult instructions for use

Primary placement in Germany; available across 19 countries total.

Trade name

Endo-Chisel, without Handle

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.

04250337101147

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.

42503371ABLACHI4Q

Reference / catalog number

TEC372620

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

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 370 MU50
• 2.6 MU50

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

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

• L1102NEUROSURGERY SPATULAS AND DISSECTORS, REUSABLE

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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