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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: —
Email: [email protected]
Phone: +73342600
PRRC Contact: Bechir Gaaloul
EUDAMED SRN: TN-MF-000011757
FDA FEI Number: —
DUNS Number: —

Catalogue (434)

Page 1 of 9

Device	Model / Reference	Registries	Class	Status
Pansement adhésif non‐tissé avec compresse absorbante Fixaderm Stérile® 9cmx15cm B.100pc	H33006	EUDAMED	Class I	Active
Gants chirurgicaux stériles non poudrés en latex Taille:7, 5	H35104	EUDAMED	Class IIa	Active
Instrument table cover 150x160cm	CTB-150X160	EUDAMED	Class I	Active
Pansement transparent avec compresse absorbante Fixaderm Stérile® eau protect 6cm x 10cm E.5pc	F16102	EUDAMED	Class I	Active
Adhesive drape 45x75 cm	ADH-45X75	EUDAMED	Class I	Active
NEODRAP® Surgical set for central catheter	KIT-006A	EUDAMED	Class I	Active
NEODRAP® Anesthesia set Set 23	KIT-023	EUDAMED	Class I	Active
Champ fenestré 45x45cm, ouverture adhésivée centrée 7x11cm	ADF-45X45-7/11C	EUDAMED	Class I	Active
Ophthalmology drape 140x160 with fluid collection pouch, with incise film aperture 6, 5x3, 5cm	CH-OPH-012	EUDAMED	Class I	Active
Shoe cover	ACC-CCH-002	EUDAMED	Class I	Active
Adhesive slit sheet 125X150cm, U rounded 10x45cm	CHU-125X150	EUDAMED	Class I	Active
Approch drape sheets 70x90cm	COP-70X90	EUDAMED	Class I	Active
COMFIT® Premium Gants chirurgicaux stériles poudrés en latex Taille: 8	H35114P	EUDAMED	Class IIa	Active
Champ adhésif 50x75 cm	ADH-50X75	EUDAMED	Class I	Active
Instrument pouch cardio 35x67cm (2 compartments)	POC-INS08	EUDAMED	Class I	Active
Pansement oculaire stérile NEOPAD® small 62mmx50mm B. 250pc	H33201	EUDAMED	Class I	Active
Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 6mm x 10cm B.100 pc	H33503	EUDAMED	Class I	Active
Fenestrated drape 200x230, with reinforcement 30x30, aperture Ø 10cm	CH-ORL-002	EUDAMED	Class I	Active
Pansement adhésif non‐tissé avec compresse absorbante Fixaderm stérile® 9x15cm E.5pc	F16005	EUDAMED	Class I	Active
Adhe-FLOW® DUO Kit cathéter d’hémodialyse fémorale double lumières FR12 L.: 30cm	DLC1230JK	EUDAMED	Class IIa	Active
Polyethylene drape 100x150cm	COP-100X150P	EUDAMED	Class I	Active
T020199	CH-GYN-007	EUDAMED	Class I	Active
Fenestrated drape 225x400cm with adhesive aperture	CH-ANGIO-011	EUDAMED	Class I	Active
Ophthalmology drape 200x230cm with 2 fluid collection pouch, with incise film aperture 6, 5x3, 5cm	543722MR2	EUDAMED	Class I	Active
Pansement oculaire stérile NEOPAD® large 92mmx66mm E.10pc	F19002	EUDAMED	Class I	Active
Compresses de gaze abdominales stériles pour laparotomie 40cm x 50cm 17fils/cm2 6plies X Ray avec lacette sachet de 5 compresses	H31213RX	EUDAMED	Class IIa	Active
Elastic cap handle covers 85x95cm	ACC-HOUS-85x95	EUDAMED	Class I	Active
Pansement sparadrap microporeux renforcé NEO‐STERILE‐STRIPS® 3mm x 7, 5cm B.100 pc	H33500	EUDAMED	Class I	Active
Compresses de gaze abdominales stériles pour laparotomie 40cm x 50cm 17fils/cm2 6plies double emballage avec lacette sachet de 5 compresses	H31213D	EUDAMED	Class IIa	Active
Champ fenestré 150x100cm, ouverture adhésivée centrée Ø 10cm	ADF-150X100-10C	EUDAMED	Class I	Active
Compresses de gaze abdominales stériles pour laparotomie 45cm x 45cm 17fils/cm2 4plies X Ray avec lacette sachet de 5 compresses	H31202RX	EUDAMED	Class IIa	Active
CO-COMFIT® Gants chirurgicaux stériles poudrés en latex Taille: 9	H35107P	EUDAMED	Class IIa	Active
Champ adhesif renforcé 170x300cm avec renfort	ADH-170X300-R	EUDAMED	Class I	Active
Compresses de gaze abdominales stériles pour laparotomie 40cm x 50cm 17fils/cm2 4plies X Ray avec lacette sachet de 2 compresses	H31201RX	EUDAMED	Class IIa	Active
TUR drape, integrated leggings, with fluid collection pouch 170/240x210cm	CH-RTU-003	EUDAMED	Class I	Active
Film adhésif transparent en polyuréthane Neofilm® 10cm x 20cm boite de 20 pièces	H33313	EUDAMED	Class I	Active
Approch drape sheets 140x225cm	COP-140X225	EUDAMED	Class I	Active
Pansement adhésif non‐tissé avec compresse absorbante Fixaderm stérile® 9x10cm E.5pc	F16004	EUDAMED	Class I	Active
Endoscopy drape 225x240cm, aperture centred Ø 8cm	CH-AUT-004	EUDAMED	Class I	Active
Approch drape sheets 90x100cm	COP-90X100	EUDAMED	Class I	Active
Elastic cap handle covers Ø 100cm	ACC-HOUS-100	EUDAMED	Class I	Active
Pansement hydrocellulaire adhésif NEOMOUSSE® Adhésif et stérile 10cm x 25cm B.:75strips	H33403	EUDAMED	Class IIa	Active
Champ fenestré 80x80cm, ouverture adhésivée Ø 8cm	ADF-80X80-8	EUDAMED	Class I	Active
Surgical drape 200x240cm, with reinforcement 30x30, adhesive aperture centred Ø 12cm	CH-AUT-007	EUDAMED	Class I	Active
CO-COMFIT® Gants chirurgicaux stériles poudrés en latex Taille: 8	H35105P	EUDAMED	Class IIa	Active
Instrument pouch 50x50cm (1 compartment)	POC-INS03	EUDAMED	Class I	Active
Fenestrated drape 70x80cm, aperture centred 11x12cm	CHF-70X80-11/12C	EUDAMED	Class I	Active
Surgical drape sheets 40x40cm	COP-40X40	EUDAMED	Class I	Active
Approch drape sheets 180x180cm	COP-180X180	EUDAMED	Class I	Active
Surgical drape 200x250cm, with reinforcement 30x30cm, adhesive opening centered 11x12cm	CH-AUT-006	EUDAMED	Class I	Active

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