Organization name

Mediplast AB

SRN

SE-MF-000000885

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  Refer to Instruction for use.
• CW262

  Device may be used multiple times on single patient. The bandage should be kept clean. If contaminated with bodily fluids it should be discarded and replaced by a new bandage.

Primary placement in Sweden; available across 20 countries total.

Trade name

not provided

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.

07395502068003

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.

73955026107136ANE

Reference / catalog number

6050937

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

Danagrip Highly stretchable tubular bandage, Size G - 12 cm x 10 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.

• M03030201TUBULAR MESH

• Class I medical devices in EUDAMED

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