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OxiStrip

Medical device information

A Class I medical device with a CE mark.

That is the advantage. Before the device goes on sale, the manufacturer carries out a conformity assessment under Regulation (EU) 2017/745: it states the intended purpose, assesses safety, and includes instructions for use. The intended purpose and contraindications are written plainly. You know what goes on your skin.

  • Class I medical device
  • CE marked under the EU Medical Device Regulation (MDR)
  • Instructions for use in every pack
  • Intended purpose and contraindications stated up front

OxiStrip products are Class I medical devices within the meaning of Regulation (EU) 2017/745 (MDR). Below you will find the regulatory information for each device: intended purpose, classification, manufacturer, instructions for use, contraindications and warnings.

OxiStrip nasal strips and OxiStrip mouth tape are Class I medical devices, CE marked under Regulation (EU) 2017/745 (MDR). [TO CONFIRM: registration status in EUDAMED / national database]

This is a medical device. Use it in accordance with the instructions for use or the label.

Our medical devices

OxiStrip Sport — nasal strips

Device name
OxiStrip Sport — nasal strips
Intended purpose
[TO FILL verbatim from the IFU] Draft: single-use external nasal dilator that mechanically widens the nasal vestibule to make breathing through the nose easier.
Classification
Class I (MDR Annex VIII, Rule 1) [TO CONFIRM]
Conformity
CE marked under Regulation (EU) 2017/745 (MDR). The EU declaration of conformity is available on request. [TO FILL: link or contact]
Basic UDI-DI
[TO FILL: Basic UDI-DI]
Manufacturer
[TO FILL: manufacturer name, full registered address]
Manufacturer SRN (EUDAMED)
[TO FILL: manufacturer SRN, e.g. PL-MF-000000000]
EU authorised representative
[TO FILL only if the manufacturer is based outside the EU: name, address — otherwise remove]
Advertiser
[TO FILL: company name, registered address, company/VAT number]
Instructions for use
[TO FILL: link to the PDF instructions for use]

Contraindications

[DRAFT — replace with the exact wording from the instructions for use / label]

  • Do not apply to damaged, irritated, sunburned or broken skin.
  • Do not use if you are allergic to any component of the adhesive.
  • Do not use after nasal surgery without your doctor’s approval.
  • Not intended for children under [TO FILL] years.

Warnings and precautions

[DRAFT — replace with the exact wording from the instructions for use / label]

  • Single use only — do not reuse.
  • Remove the strip if redness, itching or irritation occurs.
  • The device does not treat sleep apnoea. If you snore loudly with pauses in breathing, consult a doctor.
  • Do not wear for longer than [TO FILL] hours.

Reporting incidents

If a serious incident occurs in connection with the device, report it to the manufacturer ([TO FILL: e-mail / phone for incident reports]) and to the competent authority of the EU member state where you live — in Poland: the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).

This is a medical device. Use it in accordance with the instructions for use or the label.

OxiStrip — mouth tape

Device name
OxiStrip — mouth tape
Intended purpose
[TO FILL verbatim from the IFU] Draft: single-use adhesive tape applied over the lips during sleep to help keep the mouth closed and support breathing through the nose.
Classification
Class I (MDR Annex VIII, Rule 1) [TO CONFIRM]
Conformity
CE marked under Regulation (EU) 2017/745 (MDR). The EU declaration of conformity is available on request. [TO FILL: link or contact]
Basic UDI-DI
[TO FILL: Basic UDI-DI]
Manufacturer
[TO FILL: manufacturer name, full registered address]
Manufacturer SRN (EUDAMED)
[TO FILL: manufacturer SRN, e.g. PL-MF-000000000]
EU authorised representative
[TO FILL only if the manufacturer is based outside the EU: name, address — otherwise remove]
Advertiser
[TO FILL: company name, registered address, company/VAT number]
Instructions for use
[TO FILL: link to the PDF instructions for use]

Contraindications

[DRAFT — replace with the exact wording from the instructions for use / label]

  • Do not use if you cannot breathe freely through your nose (e.g. a cold, nasal congestion, nasal obstruction).
  • Do not use after consuming alcohol, sedatives or sleeping pills, or if you feel nauseous.
  • Do not use with diagnosed sleep apnoea, asthma, COPD or other respiratory conditions without consulting a doctor.
  • Do not apply to damaged or irritated skin on or around the lips.
  • Not intended for children under [TO FILL] years.

Warnings and precautions

[DRAFT — replace with the exact wording from the instructions for use / label]

  • Single use only — do not reuse.
  • The tape must be easy to remove at any time. Stop using it if you feel short of breath or anxious.
  • Remove the tape if irritation occurs.

Reporting incidents

If a serious incident occurs in connection with the device, report it to the manufacturer ([TO FILL: e-mail / phone for incident reports]) and to the competent authority of the EU member state where you live — in Poland: the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).

This is a medical device. Use it in accordance with the instructions for use or the label.

OxiStrip Combo — set: OxiStrip Sport nasal strips + OxiStrip mouth tape

Device name
OxiStrip Combo — set: OxiStrip Sport nasal strips + OxiStrip mouth tape
Intended purpose
The set contains two medical devices. Each is used according to its own intended purpose and instructions for use (see the OxiStrip Sport nasal strips and OxiStrip mouth tape pages).
Classification
Set of two Class I medical devices [TO CONFIRM: whether an MDR art. 22 system/procedure pack statement is required]
Conformity
CE marked under Regulation (EU) 2017/745 (MDR). The EU declaration of conformity is available on request. [TO FILL: link or contact]
Basic UDI-DI
[TO FILL: Basic UDI-DI of each device in the set]
Manufacturer
[TO FILL: manufacturer name, full registered address]
Manufacturer SRN (EUDAMED)
[TO FILL: manufacturer SRN, e.g. PL-MF-000000000]
EU authorised representative
[TO FILL only if the manufacturer is based outside the EU: name, address — otherwise remove]
Advertiser
[TO FILL: company name, registered address, company/VAT number]
Instructions for use
[TO FILL: link to the PDF instructions for use]

Contraindications

[DRAFT — replace with the exact wording from the instructions for use / label]

  • See the contraindications of each device in the set — nasal strips and mouth tape.

Warnings and precautions

[DRAFT — replace with the exact wording from the instructions for use / label]

  • Read both instructions for use before first use.
  • Use the mouth tape only when you can breathe freely through your nose.

Reporting incidents

If a serious incident occurs in connection with the device, report it to the manufacturer ([TO FILL: e-mail / phone for incident reports]) and to the competent authority of the EU member state where you live — in Poland: the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).

This is a medical device. Use it in accordance with the instructions for use or the label.