9115

Organization name

Bevaplast B.V.

SRN

NL-MF-000004386

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW010

  EUDAMED did not publish a description for this code.
• CW011

  Do not apply to inflamed, injured, or bleeding skin. If you experience skin irritation or itching, remove the bandage immediately and check whether you are using the correct size. Do not wear the bandage for longer periods (not longer than 2 hours continuously, or 6 hours per day) and not during sleep. If you experience numbness, skin discoloration, pain, swelling, or worsening conditions under the skin, consult your doctor before continuing to use the product. Do not use this product in combination with other compression products, creams, skin oils, etc. Consult a doctor if your questions about injuries persist or symptoms continue or worsen. In individual cases, skin reactions and irritation may occur. If these persist, discontinue use and seek medical advice. Replace the bandage if it is no longer sufficiently elastic. Inform the manufacturer and the relevant authority about serious incidents.

Primary placement in Netherlands; available across 2 countries total.

Trade name

not provided

UDI-DI code

08712175941607

Basic UDI-DI

8712175_TD_11_SPSUPFS

Reference / catalog number

9115

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

4-Way-Stretch Bandage Ankle L

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• M030499ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER