Patient Kit

Organization name

Operating Theatre Medical (Zhijiang) Co., Ltd

SRN

CN-MF-000038254

Manufacturer status

Active

Primary placement in Belgium; available across 11 countries total.

Trade name

Patient Kit

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.

06976128076842

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.

6976128076800CJ

Reference / catalog number

KPC-SMS-XXL

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

One patient gown with short sleeve, one non-woven cap, one pair of non-woven shoe covers and one pair of non-woven briefs are packed and sealed in one package.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Size XXL

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

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

• T0299PROTECTION DRAPES AND GARMENTS - OTHER

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.