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
Bandes extensibles non stériles ALVITA	ALV4278	EUDAMED	Class I	Active
Bandes extensibles non stériles MARQUE CONSEIL	3664666004122	EUDAMED	Class I	Active
Bandes de crêpe stériles double emballage	603CDS	EUDAMED	Class I	Active
Set de pose sur veines fragiles ou voie sous-cutanée, perfusion 22G	PERFU002	EUDAMED	Class IIb	Active
Bandes extensibles non stériles ALVITA	ALV4283	EUDAMED	Class I	Active
Compresses en non-tissé non stériles SYLASOFT	213	EUDAMED	Class I	Active
Set de pansement post-op petites plaies VIATRIS	3664666015302	EUDAMED	Class IIa	Active
Bande de gaze SYLAMED	802C	EUDAMED	Class I	Active
Sparadrap microporeux avec dévidoir ALVITA	6410126	EUDAMED	Class I	Active
Bande de crêpe en coton MARQUE CONSEIL	3664666003132	EUDAMED	Class I	Active
Benda Orlata ALVITA	ALV4848	EUDAMED	Class I	Active
Compresses de gaze non stériles	105	EUDAMED	Class I	Active
Set de pose sur voie veineuse périphérique, perfusion 20G	PERFU001	EUDAMED	Class IIb	Active
Bandes extensibles non stériles SYLAMED	713C	EUDAMED	Class I	Active
Bande de gaze SYLAMED	804C	EUDAMED	Class I	Active
Coton cardé écru et décontaminé	301A	EUDAMED	Class I	Active
Sparadrap extensible SylaFIX	6017147	EUDAMED	Class I	Active
Bandes extensibles non stériles GIPHAR	3664696002891	EUDAMED	Class I	Active
Set de pansement post-opératoire pour petite plaie suturée non infectée SYLASET	6022871	EUDAMED	Class IIa	Active
Champ de soins stérile SYLADRAPE	1051	EUDAMED	Class I	Active
Set de pansement post-op grandes plaies VIATRIS	3664666015326	EUDAMED	Class IIa	Active
Boules de Coton	303	EUDAMED	Class I	Active
Pansement absorbant non stérile SYLAVIT	SYLAVITNS1020	EUDAMED	Class I	Active
Compresses en non-tissé non stériles SYLASOFT	111	EUDAMED	Class I	Active
Bande de crêpe	602C	EUDAMED	Class I	Active
Compresses de gaze non stériles SYLAFIRST	101GI	EUDAMED	Class I	Active
Set de pansement plaies chroniques VIATRIS Standard	3664666015296	EUDAMED	Class IIa	Active
Bande adhésive élastique ALVITA	6410122	EUDAMED	Class I	Active
Bande de crêpe	ALV4270	EUDAMED	Class I	Active
Sparadrap perforé SYLASPAR	SYLSPAR138	EUDAMED	Class I	Active
Sparadrap microporeux avec dévidoir MARQUE CONSEIL	3664666305502	EUDAMED	Class I	Active
Compresses de gaze non stériles	103	EUDAMED	Class I	Active
Bande adhésive élastique ALVITA	6410120	EUDAMED	Class I	Active
Compresses de gaze non stériles	CG7508	EUDAMED	Class I	Active
Non-Woven Swabs MEDIBASE	111G	EUDAMED	Class I	Active
Pansement adhésif stérile avec compresse centrale SYLAPLAIE	870	EUDAMED	Class I	Active
Bande de crêpe en coton	607D	EUDAMED	Class I	Active
Bandes extensibles non stériles VITADOMIA	3664666123229	EUDAMED	Class I	Active
Elastische Fixierbinde ALIVTA	ALV5268	EUDAMED	Class I	Active
Bande de crêpe DOCTISSIMO	DS066207	EUDAMED	Class I	Active
Bande de crêpe en coton VITADOMIA	3664666123106	EUDAMED	Class I	Active
Bandes extensibles non stériles SYLAMED	702M	EUDAMED	Class I	Active
Urgosterile	754081	EUDAMED	Class I	Active
Bande élastique de contention (blanc) MARQUE CONSEIL	3664666305038	EUDAMED	Class I	Active
Bande de crêpe en coton	603D	EUDAMED	Class I	Active
Rectangles de coton BIOPADS	311	EUDAMED	Class I	Active
Bande adhésive élastique ALVITA	6410121	EUDAMED	Class I	Active
Idealbinde ALVITA	ALV5258	EUDAMED	Class I	Active
Benda Orlata ALVITA	ALV4847	EUDAMED	Class I	Active
Set de pansement plaies chroniques ZENTIVA Standard	3664666014718	EUDAMED	Class I	Active

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