Organization name

Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa

SRN

PL-MF-000052302

Manufacturer status

Active

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

• EUH 208 – Contains (name of sensitising substance). May produce an allergic reaction.

  Products made of stainless steel contain metals (in the form of alloying additives or in trace amounts) that may cause allergies (Nickel, Chromium, Cobalt). The product is contraindicated for people with allergies to any component of steel.

Primary placement in Poland; available across 32 countries total.

Trade name

Needle for ear microsurgery, 85 mm

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.

05904151409840

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-05904151409840

Reference / catalog number

LG 34

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

MDD [Directive 93/42/EEC 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

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.

• L140599EAR SURGERY INSTRUMENTS, REUSABLE - OTHER

• Class I medical devices in EUDAMED

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