Organization name

Unimax Medical Products Co., Ltd.

SRN

CN-MF-000017381

Manufacturer status

Active

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

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

• CW999

  Product for single use. Do not reuse. Do not use if the product is damaged. The product should be sterilized before use, in accordance with provisions of Instruction for Use. Do not use after the expiry date stated on the package label. For use by qualified personnel (professional users).

Primary placement in Poland; available across 19 countries total.

Trade name

OPERO gown SMS non-woven surgeon's gown, non -sterile

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.

06973490859653

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.

697349085UMNSSG57

Reference / catalog number

W2221100030_0028

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

M

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.

• T020401STANDARD SURGICAL GOWNS

• Class I medical devices in EUDAMED