Organization name

Establishment Labs

SRN

CR-MF-000008155

Manufacturer status

Active

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

• Do not resterilize
• Do not re-use

Primary placement in Belgium; available across 32 countries total.

Trade name

Motiva implants

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.

07445161008404

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.

7445161ErgoroundZen8Y

Reference / catalog number

ERSD-380Z

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 III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Breast Implant Round - Demi with Zen Ergonomix 380 cc - S

Additional information URL

https://ifu.motiva.health/

Clinical sizes

• 380 MU12

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

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

• P0601010201BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.