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.

• CW129

  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 1 country total.

Trade name

CASPAR retractor blunt blade, 65x35 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.

05904151404944

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-05904151404944

Reference / catalog number

CO 555

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.

• L110599NEUROSURGERY SPREADERS AND RETRACTORS, REUSABLE - OTHER

• Class I medical devices in EUDAMED

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