Organization name

Regen Lab SA

SRN

CH-MF-000032231

Manufacturer status

Active

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

• Do not resterilize
• Do not use if package is damaged
• Do not re-use
• Consult instructions for use
• Do not use past indicated date

Primary placement in France; available across 32 countries total.

Trade name

RegenKit Ophthalmology

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.

07640138980107

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.

B-07640138980107

Reference / catalog number

R-OPH/B

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

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.

• B0501PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS)
• B0599TOPICAL USE BLOOD COMPONENTS PREPARATION DEVICES - OTHER

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.