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

Page 3 of 9
DeviceModel / ReferenceRegistriesClassStatus
Surgical drape sheets 50x60cm COP-50X60
EUDAMED
Class IActive
TUR fluid collection pouch POC-RTU01
EUDAMED
Class IActive
Champ fenestré 100x100cm, ouverture adhésivée centrée Ø10cm ADF-100X100-10C
EUDAMED
Class IActive
Champ fenestré 45x50cm, ouverture adhésivée centrée 7x11cm ADF-45X50-7/11C
EUDAMED
Class IActive
Surgical drape 180x250cm, with reinforcement 30x30, adhesive aperture Ø 10cm 543722MR2
EUDAMED
Class IActive
Alaize slit 120X150cm, U straight 14x50cm CHU-120X150
EUDAMED
Class IActive
Approch drape sheets 90x90cm COP-90X90
EUDAMED
Class IActive
Pansement adhésif non‐tissé avec compresse absorbante Fixaderm Stérile® 9cmx30cm B.75pc H33010
EUDAMED
Class IActive
Approch drape sheets 150x100cm COP-150X100
EUDAMED
Class IActive
CO-COMFIT® Gants chirurgicaux stériles poudrés en latex Taille: 8, 5 H35106P
EUDAMED
Class IIaActive
Film adhésif transparent en polyuréthane Neofilm® 48cm x 45cm boite de 10 pièces H33307
EUDAMED
Class IActive
Compresses stériles de gaze hydrophile 10cm x 10cm 13 fils/cm2-12 plis sachet de 5 compresses H31005
EUDAMED
Class IActive
Ophthalmology drape 140x225 with 2 fluid collection pouch, with incise film aperture 6, 5x3, 5cm 543722MR2
EUDAMED
Class IActive
TUR drape, integrated leggings, with fluid collection pouch 200/260x210cm CH-RTU-001
EUDAMED
Class IActive
Approch drape sheets 90x180cm COP-90X180
EUDAMED
Class IActive
Approch drape sheets 150X150cm COP-150X150
EUDAMED
Class IActive
Champ fenestré 200x210cm, ouverture adhésivée centrée Ø 10cm ADF-200X210-10C
EUDAMED
Class IActive
Surgical drape sheets 45X45cm COP-45X45
EUDAMED
Class IActive
Laparoscopy drape 260x270cm, with integrated leggings 543722MR2
EUDAMED
Class IActive
Pansement transparent avec compresse absorbante Fixaderm Stérile® eau protect 4cm x 6cm B.300pc H33100
EUDAMED
Class IActive
Elastic cap handle covers 80x45cm ACC-HOUS-80x45
EUDAMED
Class IActive
Caesarean section fluid collection pouch POC-CSR01
EUDAMED
Class IActive
Fluoroscopy cover 100x120cm ACC-HOUS-100x120
EUDAMED
Class IActive
Film adhésif transparent en polyuréthane Neofilm® 33cm x 15cm boite de 20 pièces H33314
EUDAMED
Class IActive
Adhesive slit sheet 225X240cm, U rounded 10x80cm with shoulder arthroscopy pouch CHU-225X240
EUDAMED
Class IActive
NLPC Pouch POC-NLPC01
EUDAMED
Class IActive
Waterproof cover 90x250cm for operating table ACC-DRAP-005
EUDAMED
Class IActive
Leg cover 60x120cm ACC-JAMB-008
EUDAMED
Class IActive
Delivery drape 75x100cm, with pouch CH-GYN-004
EUDAMED
Class IActive
Laparoscopy drape 260x270cm, with integrated leggings, perineal aperture CH-LAP-004
EUDAMED
Class IActive
Champ fenestré 50x75cm, ouverture adhésivée centrée Ø 8cm ADF-50X75-8C
EUDAMED
Class IActive
Shoulder Arthroscopy drape (elastic) 200x300cm CH-EXT-200X300
EUDAMED
Class IActive
Film adhésif transparent en polyuréthane Neofilm® 60cm x 35cm boite de 10 pièces H33316
EUDAMED
Class IActive
Arthroscopy drape with fluid collection pouch 200x300cm CH-EXT-200X300-P
EUDAMED
Class IActive
Cesarean drape with pouch 260/200x335cm CH-GYN-001
EUDAMED
Class IActive
Surgical drape sheets 50x120cm COP-50X120
EUDAMED
Class IActive
Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 6mm x 3, 8cm B.100 pc H33501
EUDAMED
Class IActive
Champ adhesif 170x180cm ADH-170X180
EUDAMED
Class IActive
Surgical drape sheets 60x60cm COP-60X60
EUDAMED
Class IActive
Champ fenestré 50x60cm, ouverture adhésivée centrée Ø 6cm ADF-50X60-6C
EUDAMED
Class IActive
Instrument pouch (cardiovascular) POC-INS07
EUDAMED
Class IActive
Gyneco stockinette75x120cm ACC-JAMB-002
EUDAMED
Class IActive
Champ fenestré 75x90cm, ouverture adhésivée centrée Ø 10cm ADF-75X90-10C
EUDAMED
Class IActive
Fenestrated drape 100x150cm, aperture 7x11cm CHF-100X150-7/11
EUDAMED
Class IActive
Pansement compressif pour fistule NEO-FISTULA-PAST® 5cm x 8cm avec compresse 2cm x 3cm B. 100 pieces 10041
EUDAMED
Class IActive
Fenestrated drape 50x60cm, aperture 7x11cm CHF-50X60-7/11
EUDAMED
Class IActive
Ophthalmology drape 100x120cmwith fluid collection pouch, with incise film aperture 6, 5x3, 5cm CH-OPH-011
EUDAMED
Class IActive
Reinforced Adhesive slit sheet 225X280cm, U rounded 10x100cm CHU-225X280-R
EUDAMED
Class IActive
Perineum cover 20x40cm ACC-CACHE-001
EUDAMED
Class IActive
Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 3mmx7.5cm F19305
EUDAMED
Class IActive

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