Organization name

Advanced Sterilization Products, Inc.

SRN

US-MF-000008427

Manufacturer status

Active

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

• EUH 208 – Contains (name of sensitising substance). May produce an allergic reaction.

  Phthaldehyde

• P273 – Avoid release to the environment.
• P391 – Collect spillage.
• H411 – Toxic to aquatic life with long lasting effects.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P501 - Dispose of contents/container in accordance with local/regional/national/international regulations.

  OTHER

• P332 – If skin irritation occurs: P362 – Take off contaminated clothing and wash before reuse.
• P302 – IF ON SKIN: P353 – Rinse skin with water/shower.
• Consult instructions for use
• H317 – May cause an allergic skin reaction.
• P272 – Contaminated work clothing should not be allowed out of the workplace.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P332 – If skin irritation occurs: P313 – Get medical advice/attention.

Primary placement in Netherlands; available across 32 countries total.

Trade name

CIDEX™ OPA Chemical Disinfectant Solution

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.

10705037000098

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.

0705037A030000000000003L2

Reference / catalog number

20391

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

—

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.

• 10705037000098× 1 unitBase unit
  • 20705037000095× 4 units

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

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

• D010103ORTHOPHTALALDEHYDE FOR THE DISINFECTION OF MEDICAL DEVICES

• Class IIb medical devices in EUDAMED

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