Organization name

HAYMED INSTRUMENTS

SRN

PK-MF-000012992

Manufacturer status

Active

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

• CW011

  Never use the instrument other than intended purpose. Inappropriate selection and application of the instrument may pose harm to the user and the patient. Appropriate instrument model shall be used as per the requirement.

Primary placement in Poland; available across 32 countries total.

Trade name

Laryngoscope Handle, Reusable

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.

08964003352677

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.

8964003352HM065M

Reference / catalog number

FMG-001-2660-ST

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

F.O XENON HANDLE STUBBY

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.

• Z12021003LARYNGOSCOPES

• Class I medical devices in EUDAMED

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