LK033

Organization name

Cavex Holland BV

SRN

NL-MF-000000423

Manufacturer status

Active

E241LK0330

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• CW042

  EUDAMED did not publish a description for this code.
• CW086

  EUDAMED did not publish a description for this code.
• CW044

  EUDAMED did not publish a description for this code.
• CW096

  EUDAMED did not publish a description for this code.
• CW101

  EUDAMED did not publish a description for this code.
• CW045

  EUDAMED did not publish a description for this code.
• CW103

  EUDAMED did not publish a description for this code.
• CW104

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 15 countries total.

Trade name

not provided

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.

E241LK0330

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.

B-E241LK0330

Reference / catalog number

LK033

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.

HIBCC

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

capsule III spill 300 caps

Additional information URL

https://www.cavex.nl/wp-content/uploads/2022/10/2022-01-IFU-Cavex-Non-Gamma2-ZL709-14-MDD.pdf

Clinical sizes

No clinical sizes registered for this device.

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

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

• Q01010101AMALGAMS FOR RESTORATIVE DENTISTRY

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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