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Adhe-Els SA.

Tunisia·TN-MF-000011757

Last updated September 18, 2026

What Adhe-Els SA. makes

Adhe-Els SA manufactures a range of sterile medical consumables, including non‑woven adhesive dressings with absorbent pads, transparent dressings, and various adhesive drapes and sheets for surgical use. Their product line also covers sterile surgical gloves, shoe covers, instrument table covers, and specialized sets such as the NEODRAP® central catheter and anesthesia kits, as well as ophthalmic drapes with fluid collection pouches.

The devices are classified as Class I or Class IIa medical devices and are listed in the European Database on Medical Devices (EUDAMED). Adhe-Els SA is based in Tunisia.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Adhe-Els SA manufacture?

Adhe-Els SA manufactures sterile medical consumables such as non-woven adhesive dressings with absorbent pads, transparent adhesive dressings, surgical gloves, shoe covers, instrument table covers, adhesive drapes and sheets, and specialized sets like NEODRAP® for central catheter and anesthesia use, as well as ophthalmic drapes with fluid collection pouches. These products are designed for single-use in clinical settings to support wound management and surgical procedures.

Where is Adhe-Els SA based?

Adhe-Els SA is based in Tunisia, as indicated by the country code TN in the provided data. This specifies the country where the manufacturer is located, which is relevant for regulatory traceability and jurisdiction under which the company operates.

In which regulatory registry are Adhe-Els SA's devices listed?

Adhe-Els SA's devices are listed in EUDAMED, the European Database on Medical Devices. This registry is used to track medical devices available on the European market, and inclusion in EUDAMED indicates that the company's devices have been registered for distribution in accordance with EU medical device regulations.

How are Adhe-Els SA's devices classified under medical device regulations?

Adhe-Els SA's devices are classified as either Class I or Class IIa medical devices. This classification reflects the level of risk associated with the devices, with Class I being low risk and Class IIa being medium risk, determining the applicable conformity assessment procedures under EU regulations.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Tunisia
Address
Km128, Km 128 Industrial area Kalaa Kebira 4060 Sousse Tunisia BP84, Kalaa Kebira, Sousse , Tunisia
Website
www.adhe-els.com.tn

This website had an invalid or expired security certificate when we last checked. Last checked 2026-09-18.

LinkedIn
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Facebook
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Phone
+73342600
PRRC Contact
Bechir Gaaloul
EUDAMED SRN
TN-MF-000011757
FDA FEI Number
—
DUNS Number
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Catalogue (434)

Page 9 of 9
DeviceModel / ReferenceRegistriesClassStatus
Compresses stériles de gaze hydrophile 5cm x 5cm 17 fils/cm2- 12 plis sachet de 5 compresses H31021
EUDAMED
Class IActive
Champ adhésif 100x120cm ADH-100X120
EUDAMED
Class IActive
Surgical drape sheets 35x45cm COP-35X45
EUDAMED
Class IActive
Instrument table cover 140x240cm CTB-140X240
EUDAMED
Class IActive
Hip drape (elastic) 240x300cm CH-EXT-240X300
EUDAMED
Class IActive
Compresses stériles de gaze hydrophile 10cm x 20cm 17 fils/cm2 -12 plis sachet de 10 compresses H31012
EUDAMED
Class IActive
Pansement transparent avec compresse absorbante Fixaderm Stérile® eau protect 8cm x 12cm E.5pc F16103
EUDAMED
Class IActive
Leg cover 36, 5x66cm ACC-JAMB-001
EUDAMED
Class IActive
COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille:7 H35112P
EUDAMED
Class IIaActive
Fenestrated drap 200x270, with reinforcement 30x30, aperture 8x12cm and Velcro fastener CH-ORL-004
EUDAMED
Class IActive
Compresses de gaze abdominales stériles pour laparotomie 40cm x 50cm 17fils/cm2 4 plies double emballage avec lacette sachet de 2 compresses H31201D
EUDAMED
Class IIaActive
Film adhésif transparent en polyuréthane Neofilm® 33cm x 30cm boite de 20 pièces H33306
EUDAMED
Class IActive
Pansement hydrocellulaire adhésif NEOMOUSSE® Adhésif et stérile 9cmx10cm F20101
EUDAMED
Class IIaActive
Fenestrated drape 140x200cm, aperture 20x20cm CHF-140X200-20x20
EUDAMED
Class IActive
Reinforced Adhesive slit sheet 225X260cm, U rounded 10x100cm with perineum cover CHU-225X260-P
EUDAMED
Class IActive
Adhesive slit sheet 150X200cm, U rounded 10x65cm CHU-150X200
EUDAMED
Class IActive
Surgical drape sheets 45x75cm COP-45X75
EUDAMED
Class IActive
Film adhésif transparent en polyuréthane Neofilm® 80cm x 60cm boite de 10 pièces H33310
EUDAMED
Class IActive
Pansement oculaire stérile NEOPAD® medium 82mmx57mm E.10pc F19001
EUDAMED
Class IActive
NEODRAP Champ latéral adhésif 100x100cm ADH-100X100
EUDAMED
Class IActive
Upper extremity drape (elastic) 225x320cm, aperture with Ø7cm CH-EXT-225X320
EUDAMED
Class IActive
Compresses de gaze abdominales stériles pour laparotomie 40cm x 50cm 17fils/cm2 4plies double emballage X Ray avec lacette sachet de 2 compresses H31201RXD
EUDAMED
Class IIaActive
NEODRAP® Surgical gowns set KIT-003
EUDAMED
Class IActive
Champ adhesif renforcé 180x260cm ADH-180x260-R
EUDAMED
Class IActive
Champ de tête adhésif 150x240cm ADH-150X240
EUDAMED
Class IActive
Pansement transparent avec compresse absorbante Fixaderm Stérile® eau protect 10cm x 30cm B.75pc H33112
EUDAMED
Class IActive
COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille:6, 5 H35111P
EUDAMED
Class IIaActive
Champ adhésif renforcé 200x225cm ADH-200X225-R
EUDAMED
Class IActive
Pansement transparent avec compresse absorbante Fixaderm Stérile® eau protect 4cmx6cm E.15pc F16108
EUDAMED
Class IActive
Instrument pouch 45x45cm (2 compartments) POC-INS3SE
EUDAMED
Class IActive
Upper extremity drape (elastic)200x310cm CH-EXT-200X310
EUDAMED
Class IActive
Adhe-FLOW® DUO Kit cathéter d’hémodialyse fémorale double lumières FR12 L.: 20cm DLC1220JK
EUDAMED
Class IIaActive
Co-Comfit® /comfit® H35101P/ H35102P/ H35103P/ H35104P/ H35105P/ H35106P/ H35111P/ H35110P/H35112P/ H35113P/ H35114P/ H35115P
EUDAMED
Class IIaActive
Adhe-FLOW® MONO Désilet kit cathéter d’hémodialyse fémorale mono lumière FR10 L.: 18cm SLC-1018DK2
EUDAMED
Class IIaActive

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