Organization name

SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.

SRN

CN-MF-000032018

Manufacturer status

Active

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

• P103 – Read label before use.

Primary placement in Germany; available across 32 countries total.

Trade name

Video Laryngoscope

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.

06970831727497

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.

697083172iS3ARB

Reference / catalog number

17-237

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

Insight Workstation is a powerful workstation compatible with all Insighters video laryngoscope handles via cable/wireless module, it is designed and developed to assist physicians in Anesthesiology, ICU, ER, Respiratory Care to do endotracheal intubation, continuous airway monitoring, and airway management tele-medicine. The insight workstation should be used only by individuals who have been trained and authorized by a physician or the institution providing patient care.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 50/60Hz

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• R010280LARYNGEAL MASKS AND TUBES - ACCESSORIES

• Class I medical devices in EUDAMED

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