Organization name

Oscimed SA

SRN

CH-MF-000009605

Manufacturer status

Active

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

• Caution
• Caution, sharp edges
• Consult instructions for use
• Warning; Electricity

  Class II device with double electrical insulation, without protective grounding.

• Warning; Hot surface
• The device is designed to meet the requirements of IEC 60601-1-2: 2015 regarding electromagnetic compatibility; however, certain equipment may unintentionally emit strong RF signals that may interfere with the device. It should be kept away from all other electrical devices. (In accordance with chapter 7.9.2.2 of IEC 60601-1-2).

  OTHER

• Type B applied part

Primary placement in France; available across 32 countries total.

Trade name

OSCIMED ERGO II

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.

07640104923411

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.

764010492PLASTERSAWEV

Reference / catalog number

OSC 340-CH

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

Medical device intended for the removal of plaster or synthetic resin immobilisation casts. All other use is strictly prohibited. In particular, this device is not designed for use where the blade comes into voluntary contact with the patient or for surgical procedures.

Additional information URL

https://www.oscimedsa.com/

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.

• Z12139005PLASTER CAST SAWS

• Class I medical devices in EUDAMED

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