Organization name

Jiangsu Nanfang Medical Co., Ltd.

SRN

CN-MF-000027296

Manufacturer status

Active

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

• CW011

  Patients with skin allergies are prohibited from using it.a)This product is sterilized with ethylene oxide. b)The product is for single use only, do not reuse it. c)Do not use if the inner package is damaged, damp, or discolored during use. d)If the inner packaging is opened, please use it immediately. e)Use with caution for patients with skin allergies. f)The product is valid for three years. It is forbidden to use after validity period. g)When using, please cover the wound with the wound protection pad, and do not directly apply the adhesive part of the backing to the wound. h)Used Sterile Dressings Adhesive shall be treated as medical waste and shall not be discarded at will.

Primary placement in Austria; available across 32 countries total.

Trade name

Sterile Dressings Adhesive

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.

06922096406372

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.

69220964SDA01MH

Reference / catalog number

/

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 6.8–7.2 MU10
• 5.8–6.2 MU10

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

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

• M04010101NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD
• M04010102POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD

• Class I medical devices in EUDAMED

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