Organization name

Zeltiq Aesthetics, Inc.

SRN

US-MF-000004536

Manufacturer status

Active

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

• Consult instructions for use
• Type BF applied part
• Refer to instruction manual/booklet
• MR UNSAFE

Primary placement in Ireland; available across 13 countries total.

Trade name

CoolSculpting Elite Applicator Curve 80 (C80)

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.

00816417021558

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.

0816417020001SL

Reference / catalog number

CS-A3-08C-00

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The CoolSculpting® Elite System is a non-invasive cooling device that applies controlled cooling to a treatment site on the patient’s skin. The device is intended to be used for fat layer reduction through cold-assisted lipolysis for aesthetic purposes.

Additional information URL

https://devices.abbvie.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.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

• Class IIb medical devices in EUDAMED

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