Organization name

Xinle Huabao Medical Products Co., Ltd.

SRN

CN-MF-000008893

Manufacturer status

Active

Primary placement in Austria; available across 32 countries total.

Trade name

EXCELLENT GREEN SHIELD

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.

16974802581719

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.

B-16974802581719

Reference / catalog number

Ⅱ型（M）

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The Isolation Gown is used for general isolation in out patient clinics, wards, inspection rooms ,etc.of medical institutions.It is applicable to doctors, Nurses, patients, medical institution, hospitals and laboratories visited staff. The product is for single use only, and provided sterile.

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.

• T0205NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

• Class I medical devices in EUDAMED

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