Organization name

Wipak Packaging (Changshu) Co., Ltd.

SRN

CN-MF-000009613

Manufacturer status

Active

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

• Do not re-use

Primary placement in Finland; available across 32 countries total.

Trade name

STERIKING® LT-Blueline Self-Sealable Pouches

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.

06974610340402

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.

697461034ST16010HM

Reference / catalog number

LTSS4

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

1000

Additional product description

STERIKING® LT-Blueline Self-Sealable Pouches are designed to be used by trained healthcare professionals in healthcare facilities to allow sterilization, maintain sterility, and enable aseptic presentation of a packed and processed device, and they are for single use only.

Additional information URL

https://www.steriking.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.

• S01010201FLAT STERILISATION POUCHES, TYVEK/PLASTIC FILM

• Class I medical devices in EUDAMED

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