Organization name

Advanced Sterilization Products, Inc.

SRN

US-MF-000008427

Manufacturer status

Active

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

• P285 – In case of inadequate ventilation wear respiratory protection.
• H334 – May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P307 – IF exposed: P362 – Take off contaminated clothing and wash before reuse.
• P264 – Wash thoroughly after handling.
• H315 – Causes skin irritation.
• H318 – Causes serious eye damage.
• H412 – Harmful to aquatic life with long lasting effects.
• EUH 208 – Contains (name of sensitising substance). May produce an allergic reaction.

  subtilisin

• P273 – Avoid release to the environment.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• P305 – IF IN EYES: P310 – Immediately call a POISON CENTER or doctor/physician.
• P501 - Dispose of contents/container in accordance with local/regional/national/international regulations.

  OTHER

• Consult instructions for use

Primary placement in Netherlands; available across 32 countries total.

Trade name

CIDEZYME BIOCLEAN™ Enzymatic Detergent

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.

10705037070718

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.

0705037A180000000000018UM

Reference / catalog number

88301

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://eifu.asp.com/

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 10705037070718× 1 unitBase unit
  • 20705037070739× 4 units

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

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

• D0801ENZYMATIC DETERGENTS FOR MEDICAL DEVICES

• Class I medical devices in EUDAMED

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