ASISU-01

Organization name

Oasicare ApS

SRN

DK-MF-000050264

Manufacturer status

Active

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

• CW011

  1) The device should only be used once to avoid device failure or sub-optimal performance, and infections. 2) Dispose of the device as waste per local regulations.
• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW999

  Contraindications: • The device is not intended for patients with known perineal abnormalities or complications requiring surgical intervention during delivery. • The device is not intended for use in births requiring instrumental intervention. • No side-effects observed upon the use of the device as intended.
• CW999

  Precaution: • Position the outer part according to the woman’s anatomy so that it does not cover or contact the anus. If necessary, trim the device before application to ensure correct fit. • Where episiotomy is clinically indicated, it takes priority over use of the device. The midwife shall ensure that the device does not interfere with performance of the episiotomy.

Primary placement in Denmark; available across 1 country total.

Placed on the market in Denmark; per-country availability dates not published.

Trade name

not provided

UDI-DI code

05746000005304

Basic UDI-DI

574600000530ASISUJV

Reference / catalog number

ASISU-01

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

ASISU® is a medical device intended for use by qualified birth attendants during the second stage of vaginal childbirth, particularly during the crowning phase. The device consists of an internal part positioned in the vaginal canal under the fetal head and an external part placed on the perineal skin, connected by a flexible neck at the posterior fourchette. The device provides mechanical support to the perineum and helps distribute forces during fetal head expulsion with the aim of reducing the risk of perineal tears. The device is supplied ready to use in a pouch allowing visual inspection before opening.

Additional information URL

https://ifu.oasi.care/

Clinical sizes

No clinical sizes registered for this device.

• U1099OBSTETRICS DEVICES - OTHER

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

This device is not currently linked to any other device.