Organization name

Endo-Therapeutics Inc.

SRN

US-MF-000002267

Manufacturer status

Active

Primary placement in Malta; available across 25 countries total.

Trade name

Catchem'

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.

00816207020389

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.

081620702polyptrapAK

Reference / catalog number

ET2213

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

Polyp Trap, 4 Chamber, Fixed

Additional information URL

https://endotherapeutics.com/instructions-for-use/

Clinical sizes

No clinical sizes registered for this device.

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

• 00816207020389× 1 unitBase unit
  • 10816207020386× 12 units

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

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

• G0399DIGESTIVE ENDOSCOPY DEVICES - OTHER

• Class I medical devices in EUDAMED

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