Laboratoires URGO HEALTHCARE

Certificate 10000452411-PA-NoMA-FRA

Rev. 7Issued

Valid until: Dec 20, 2027

Certificate 10000452411-PA-NoMA-FRA is a valid Quality management system issued to Laboratoires URGO HEALTHCARE and registered in EUDAMED. Valid until December 20, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 10000452411-PA-NoMA-FRA
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 246010000452411-PA-NoMA-FRA7

Validity

Issued: Dec 20, 2022
Valid from: Dec 20, 2022
Valid until: Dec 20, 2027

Manufacturer

Manufacturer: Laboratoires URGO HEALTHCARE
Manufacturer SRN: FR-MF-000001538
Manufacturer country: France

Notified body

Notified body
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

: Yes
: No
: No
: No
: Yes
: No
: No
: Yes
: No
: No
: No
: No

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa28Class I2Class III2

32 scopes

The medical device is a dialysed, sterilized, undiluted, hypertonic solution of seawater presented in an aerosol bottle for nasal use.
Class IIa
The medical device is a dialysed, sterilized solution of seawater presented in an aerosol bottle for nasal use.
Class IIa
The medical device is a saline solution enriched with sea water, presented in an aerosol bottle, intended for nasal hygiene.
Class IIa
The medical device is an isotonic aqueous solution presented in an aerosol bottle. It is supplied in a pressurized container for the regular hygiene of the external auditory canal and the prevention of the formation of ear wax plugs.
Class IIa
The medical device is a sterile adhesive plaster intended for protection of surgical incisions, acute sutured wounds and superficial nonsutured wounds.
Class I
The medical device is a non-sterile, and single-use adhesive dressing with a central protective foam disc containing inside a salicylate paste with 40% w/w salicylic acid.
Class III
The medical device is a non-sterile, ready-to-use liquid dressing presented in a glass bottle with an applicator, for the protection and treatment of small linear superficial wounds, which include cracks, fissures, crevices and little cuts.
Class IIa
The medical device is a sterile precut strips, made of non woven polyester support coated with acrylic adhesive mass in a sterile peel sachet, for use in superficial wounds and surgical incisions
Class IIa
The medical device is a non-sterile hydrocolloid dressing indicated for the treatment of blisters.
Class IIa
The medical device is a non-sterile, ready-to-use liquid dressing presented in a glass bottle with an applicator, for use in oral mucosa.
Class IIa
The medical device is a non-sterile, ready-to-use liquid dressing presented in a glass bottle with single-used spatulas,for use in cold sore also known as herpes labialis.
Class IIa
The medical device is a sterile adhesive dressing ready to use made of a non-adherent mesh impregnated with lipido colloid mass and an absorbent pad. It is intended for treatment of 1st degree and 2nd degree superficial burns and superficial wounds
Class IIa
The medical device is a flexible sterile tulle ready to use non adherent mesh impregnated with lipido colloid mass. It is intended for treatment of 1st and 2nd degree superficial burns and superficial wounds
Class IIa
The medical device is a sterile transparent adhesive dressing ready to use made of a non adherent mesh impregnated with lipido colloid mass and an absorbent pad, intended for the treatment of 1st and 2nd degree superficial burns and superficial wounds
Class IIa
The medical device is a ready to use liquid dressing intended for superficial wounds
Class IIa
The medical device is a ready to use non-sterile hydrocolloid pad dressing intended for superficial wounds and for the treatment and prevention of corns and blisters
Class IIa
HUMER Blocked Nose – 100% sea water – nasal spray
Class IIa
HUMER, sterile physiologic sea water / HUMER Nasal Hygiene – 100% sea water – nasal spray PRIMOPLAST, Nasal spray 100% sea water
Class IIa
HUMER Nasal Hygiene – Saline Solution – nasal spray CARREFOUR baby nasal spray enriched with seawater CARREFOUR nasal spray MERCUROCHROME Baby Nasal spray enriched with sea water MERCUROCHROME, nasal spray MOTS D'ENFANTS nasal spray
Class IIa
HUMER, ear Spray MERCUROCHROME, ear spray CARREFOUR, ear spray
Class IIa

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