Question 1

What types of medical devices does Laboratoire SYLAMED manufacture?

Accepted Answer

Laboratoire SYLAMED specializes in producing a range of medical dressings and accessories. These include non-sterile and sterile elastic bandages (such as ALVITA and MARQUE CONSEIL), cotton and crepe bandages, non-woven compresses (like SYLASOFT), and specialized sets for medical procedures. Examples include sets for vein access (e.g., 22G perfusion sets for fragile veins) and post-operative wound care (e.g., small wound dressings under the VIATRIS brand). The company also manufactures items like micropore tape with a dispenser and gauze strips.

Question 2

Where is Laboratoire SYLAMED based, and what does this mean for its regulatory compliance?

Accepted Answer

Laboratoire SYLAMED is based in France, which means its devices must comply with the European Union’s Medical Device Regulations (MDR). Since the company’s products are registered in the EU’s eudamed database, this indicates they are intended for the European market and follow EU regulatory requirements. However, compliance and authorization are determined on a per-device basis, not the company itself.

Question 3

Which EU regulatory database lists Laboratoire SYLAMED’s devices?

Accepted Answer

Laboratoire SYLAMED’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This database is used to track devices that have undergone the necessary conformity assessment procedures under EU regulations, such as CE marking for devices classified as Class I, Class IIa, or Class IIb. Listing in eudamed confirms the devices are accounted for in the EU’s regulatory framework, but individual devices must still meet their specific classification requirements.

Question 4

How are Laboratoire SYLAMED’s devices classified under EU regulations?

Accepted Answer

Laboratoire SYLAMED’s devices fall into three classification categories under the EU Medical Device Regulations: Class I, Class IIa, and Class IIb. Classification depends on factors like the device’s intended use, duration of contact with the body, and potential risks. For example, non-sterile elastic bandages (like ALVITA) are typically Class I, while specialized sets for vein access (e.g., 22G perfusion sets) may be classified as Class IIa or IIb due to higher risk factors. The classification determines the regulatory pathway and conformity assessment requirements each device must follow.

Device	Model / Reference	Registries	Class	Status
Bande de contention cohésive couleur chair COHESYL	3664666210042	EUDAMED	Class I	Active
Bande adhésive élastique VITADOMIA	3664666123700	EUDAMED	Class I	Active
Bande de contention cohésive et élastique (chair) ALVITA	6410113	EUDAMED	Class I	Active
Compresses en non-tissé non stériles PMD	CP7575	EUDAMED	Class I	Active
Set de pansement pour plaies chroniques ALVITA Standard	1382883	EUDAMED	Class I	Active
Bande de crêpe	604C	EUDAMED	Class I	Active
Bandes extensibles non stériles ALVITA	ALV4280	EUDAMED	Class I	Active
Urgosterile	601222	EUDAMED	Class I	Active
Carrés de coton BIOPADS	310	EUDAMED	Class I	Active
Sparadrap non tissé extensible	3664666305304	EUDAMED	Class I	Active
Cerotto Microporoso - Rocchetto	ALV5334	EUDAMED	Class I	Active
Sparadrap microporeux avec dévidoir ALVITA	6410128	EUDAMED	Class I	Active
Set de pansement post-opératoire pour grandes plaies suturées et non infectées ALVITA	1313882	EUDAMED	Class IIa	Active
Rouleau de coton	301B	EUDAMED	Class I	Active
Bandes extensibles non stériles SYLAMED	703C	EUDAMED	Class I	Active
Pansement absorbant stérile SYLAVIT	2067907	EUDAMED	Class I	Active
Set de pansement pour plaies chroniques SYLASET Standard	6621005	EUDAMED	Class I	Active
Non sterile Gauze swabs	ALV5248	EUDAMED	Class I	Active
Pansement absorbant stérile SYLAVIT	2067882	EUDAMED	Class I	Active
Urgosterile	754082	EUDAMED	Class I	Active
Set de pansement post-opératoire moyennes plaies ZENTIVA	3664666014671	EUDAMED	Class IIa	Active
Bande de crêpe en coton GIPHAR	Bande de crêpe en coton GIPHAR	EUDAMED	Class I	Active
Compresses de gaze non stériles	207	EUDAMED	Class I	Active
Bandes extensibles non stériles GIPHAR	3664696002907	EUDAMED	Class I	Active
Bande de crêpe en coton	605D	EUDAMED	Class I	Active
Urgoderm	754106	EUDAMED	Class I	Active
Bande de crêpe	ALV4268	EUDAMED	Class I	Active
Bandes extensibles non stériles MARQUE CONSEIL	3664666004047	EUDAMED	Class I	Active
Compresses de gaze non stériles	110	EUDAMED	Class I	Active
Urgoderm	754107	EUDAMED	Class I	Active
Bandes extensibles non stériles VITADOMIA	3664666123205	EUDAMED	Class I	Active
Pansements multi-formats	3664666127005	EUDAMED	Class I	Active
Set de pansement post-opératoire pour petites plaies suturées et non infectées ALVITA	1325589	EUDAMED	Class IIa	Active
Sparadrap microporeux SylaPORE	6621018	EUDAMED	Class I	Active
Compresses de gaze non stériles	CG0505	EUDAMED	Class I	Active
Set de pansement post-opératoire petites plaies ZENTIVA	3664666014695	EUDAMED	Class IIa	Active
Urgosterile	754085	EUDAMED	Class I	Active
Bandes extensibles non stériles ALVITA	ALV4276	EUDAMED	Class I	Active
Compresses en non-tissé non stériles SYLASOFT	117	EUDAMED	Class I	Active
Sparadrap extensible SylaFIX	6017149	EUDAMED	Class I	Active
Urgoderm	601233	EUDAMED	Class I	Active
Bande adhésive élastique SYLAPLAST Sport	SYLAPLAST20	EUDAMED	Class I	Active
Compresses de gaze non stériles	CG1016	EUDAMED	Class I	Active
Bande de crêpe en coton VITADOMIA	3664666123113	EUDAMED	Class I	Active
Bande de crêpe en coton GIPHAR	3664696002785	EUDAMED	Class I	Active
Urgosterile	754087	EUDAMED	Class I	Active
Bande adhésive élastique SYLAPLAST Sport	6004511SY	EUDAMED	Class I	Active
Bande de crêpe en coton	602D	EUDAMED	Class I	Active
Compresses de gaze stériles STERIPAN	312160	EUDAMED	Class I	Active
Bandes extensibles non stériles SYLAMED	702C	EUDAMED	Class I	Active

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