Organization name

IC Biomedical, LLC

SRN

US-MF-000024845

Manufacturer status

Active

Primary placement in Germany; available across 32 countries total.

Trade name

LS2000

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.

00850038669379

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.

0850038669140W5

Reference / catalog number

LS2000

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 IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Cryogenic Storage and Transportation Vessels from IC Biomedical are medical devices designed for cryogenic long-term storage and transportation of canisters or vials with biological specimens of human origin, such as cord blood, stem cells or semen for subsequent research or introduction into the human body at extremely low temperatures of between -100°C and -196°C using liquid nitrogen as a cryogenic agent at normal atmospheric pressure.

Additional information URL

https://icbiomedical.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.

• W020702CRYOGENICS / FROZEN

• Class IIa medical devices in EUDAMED

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