Symbols
Glossary
Akzenta International SA
Via Giuseppe Motta, 24
CH-6830, Chiasso
Switzerland
T: +41 (0) 91 921 14 92
E: business@akzenta.ch
Via Giuseppe Motta, 24
CH-6830, Chiasso
Switzerland
T: +41 (0) 91 921 14 92
E: business@akzenta.ch
| Symbol | Title | Description |
|---|---|---|
| Manufacturer | Name and address of the manufacturer shall be provided adjacent to the symbol. | |
| Authorized representative (EU) | Name and address of the authorized representative shall be provided adjacent to the symbol. | |
| Importer | Name and address of the importer shall be provided adjacent to the symbol. | |
| Distributor | Name and address of the distributor shall be provided adjacent to the symbol. | |
| Date of manufacture | Indicates the date when the device was manufactured. | |
| Use-by date | Device shall not be used after the indicated date. | |
| Batch code | Indicates the manufacturer’s batch or lot number. | |
| Catalogue number | Indicates the manufacturer’s catalogue or reference number. | |
| Serial number | Identifies a specific device by serial number. | |
| Consult instructions for use | User must consult the instructions for use. | |
| Temperature limit | Upper and lower temperature limits are indicated. | |
| Do not re-use | Medical device intended for single use only. | |
| In vitro diagnostic medical device | Indicates an in vitro diagnostic medical device. | |
| Unique device identifier | Indicates the unique device identification carrier. | |
| CE mark | Indicates conformity with applicable EU regulations. | |
| Restricted device (US) | Sale or use restricted to order of a licensed healthcare practitioner. |
| Symbol | Title | Description |
|---|---|---|
|
Manufacturer | This symbol shall be accompanied by the name and address of the manufacturer adjacent to the symbol. |
|
Authorized representative in the European Community/ European Union | This symbol shall be accompanied by the name and address of the authorized representative, adjacent to the symbol. |
|
Date of manufacture | This symbol shall be accompanied by a date to indicate the date of manufacture. |
|
Use-by date | This symbol shall be accompanied by a date to indicate that the medical device should not be used after the end of the year, month or day shown. |
|
Batch code | This symbol shall be accompanied by the manufacturer’s batch code adjacent to the symbol. |
|
Catalogue number | This symbol shall be accompanied by the manufacturer’s catalogue number adjacent to the symbol. |
|
Serial number | Indicates the manufacturer’s serial number so that a specific medical device can be identified. |
|
Importer | This symbol shall be accompanied by the name and address of the importing entity adjacent to the symbol. |
|
Distributor | This symbol shall be accompanied by the name and address of the distributing entity adjacent to the symbol. |
|
Consult instructions for use or consult electronic instructions for use | Indicates the need for the user to consult the instructions for use |
|
Temperature limit | The upper and lower limits of temperature shall be indicated adjacent to the upper and lower horizontal lines. |
|
Do not re-use | Indicates a medical device that is intended for one single use only. |
|
In vitro diagnostic medical device | Indicates a medical device that is intended to be used as an in vitro diagnostic medical device. |
|
Contains sufficient for <n> tests | Indicates the total number of tests that can be performed with the medical device. The number of tests that can be performed with the medical device shall appear adjacent to the symbol. |
|
Unique device identifier | This symbol may be used when multiple data carriers are present on the label. If used, this symbol shall be placed adjacent to the unique device identifier carrier. |
|
For IVD Performance evaluation only | Indicates an in vitro diagnostic medical device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use. |
|
CE mark with four-digital identification number of NB | A CE marking followed by a four-digit identification number indicates that a Notified Body (NB) was involved in conformity assessment. CE 0123 shows that TÜV SÜD was the Notified Body involved in conformity assessment. |
|
CE mark | On commercial products, the letters CE (as the logo) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards according IVDD or IVDR. |
|
Restricted devices in US | Indicates a medical device that can only be sold, distributed or used upon the order of an authorized healthcare provider in the USA. |
|
NA | The Unique Device Identification (UDI) is a worldwide system for uniform product labelling of medical devices and allows to trace medical devices quickly and easily from the manufacturer to the user. |
No matches.
