Organization name

Suzhou Colour-way New Material Co., Ltd.

SRN

CN-MF-000027396

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

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

Primary placement in Germany; available across 32 countries total.

Trade name

Male Latex Condoms

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.

06925634024359

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.

69256340MLC3H

Reference / catalog number

55mm±2mm

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

250000

Additional product description

Cherry Flavored, thickness: 0.065±0.015mm

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.

• U110101CONDOMS

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.