Organization name

Advanced Sterilization Products, Inc.

SRN

US-MF-000008427

Manufacturer status

Active

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

• CW999

  Observe good industrial hygiene practices.
• CW999

  Store away from incompatible materials.
• CW203

  EUDAMED did not publish a description for this code.
• CW999

  Dispose of waste and residues in accordance with local authority requirements.
• CW167

  EUDAMED did not publish a description for this code.
• CW185

  EUDAMED did not publish a description for this code.
• CW138

  EUDAMED did not publish a description for this code.
• CW313

  EUDAMED did not publish a description for this code.
• CW172

  EUDAMED did not publish a description for this code.
• CW089

  EUDAMED did not publish a description for this code.
• CW129

  Subtilisin
• CW096

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW999

  Wash hands after handling.
• CW010

  EUDAMED did not publish a description for this code.
• CW159

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 32 countries total.

Trade name

CIDEZYME™ Enzymatic Detergent 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.

10705037018161

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.

0705037A100000000000010HD

Reference / catalog number

2260

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.

• 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.