D-KAT (T-TYPE)

Organization name

Keeler Ltd

SRN

GB-MF-000009031

Manufacturer status

Active

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

• Do not use if package is damaged

  • Check your Keeler product for signs of transport / storage damage prior to use.

• Refer to instruction manual/booklet

  • Always carefully observe the safety rules and other precautions published herein. • Only decontaminate / clean in accordance with a method given in Cleaning (Section 4) of this instruction manual. • Never use the instrument if the ambient temperature, atmospheric pressure, and/or relative humidity are outside the limits specified in this manual. • Should the instrument suffer shocks (for example, should it accidentally fall), follow the check procedure outlined in the 'Servicing and Calibrations' (Section 12); if necessary, return the instrument to the manufacturer for repair. • Use only the listed accessories in conjunction with the instrument; use said accessories only in accordance with the procedures set forth in the instruction manuals.

• Consider hazards from magnetic fields

  • Electrical equipment can be affected by electromagnetic interference. If this occurs whilst using this equipment, switch the unit off and reposition.

• P232 – Protect from moisture.

  • For indoor use only (protect from moisture). • This product should not be immersed in fluid.

Primary placement in Finland; available across 12 countries total.

Trade name

D-KAT (T-TYPE)

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.

05055272712200

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-05055272712200

Reference / catalog number

2414-P-2032

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

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

Status

On the market

Quantity

1

Additional product description

APPLANATION TONOMETER

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Z12120122TONOMETERS

• Class IIa medical devices in EUDAMED

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