Enzymex L9 - 5L

Organization name

FRANKLAB

SRN

FR-MF-000013243

Manufacturer status

Active

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

• GHS05 -Danger or Warning -Corrosive cat. 1
• GHS09 - Warning (for cat. 1)- (for cat. 2 no signal word) Environment
• H314 – Causes severe skin burns and eye damage.
• H410 – Very toxic to aquatic life with long lasting effects.
• P273 – Avoid release to the environment.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P303 – IF ON SKIN (or hair): P310 – Immediately call a POISON CENTER or doctor/physician.
• P305 – IF IN EYES: P310 – Immediately call a POISON CENTER or doctor/physician.
• P303 – IF ON SKIN (or hair): P353 – Rinse skin with water/shower.
• P303 – IF ON SKIN (or hair): P361 – Remove/Take off immediately all contaminated clothing.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• Do not re-use

  Use the pre-disinfecting bath only once (or follow the local recommendations

• Do not use past indicated date
• P233 – Keep container tightly closed.
• Do not mix with other products. Eliminate the product and packaging as hazardous waste under the full responsibility of the holder of the waste. Do not throw the residues into drains and watercourses. Any serious incident relating to the device must be notified to the manufacturer and the competent authority.

  OTHER

Primary placement in France; available across 13 countries total.

Trade name

Enzymex L9 - 5L

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.

03701387500295

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-03701387500295

Reference / catalog number

1043505

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

Enzymatic disinfectant detergent for pretreatment of medical devices. Solution to be diluted to 0.5% (5mL/L) with a contact time of 5 minutes for bactericidal, yeasticidal and virucidal activity, to 1% (10mL/L) with a contact time of 30 minutes for Tuberculocidal activity. Exclusive use by professionals for the pretreatment of invasive medical devices requiring disinfection according to their instructions for use, such as surgical instrument, operating room equipment and endoscopes. Packaging: 5L can

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.

• D99DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER

• Class IIb medical devices in EUDAMED

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