Question 1

What types of medical devices does Medical Z manufacture?

Accepted Answer

Medical Z specializes in medical-grade undergarments and support garments. These include padded and adjustable bras, liposuction-style panties with elevated thigh and buttock support, body shapers for contouring, and a pediatric sternal conformer with gel padding. The designs often incorporate features like Coolmax fabric, reinforced foundations, and custom modifications such as extended thigh coverage or detachable straps.

Question 2

Where is Medical Z based, and under which regulatory authority do its devices fall?

Accepted Answer

Medical Z is based in France, operating under the European Union’s regulatory framework. Since all its devices are classified as Class I, they must comply with EU Medical Device Regulation (MDR) requirements, specifically undergoing conformity assessment via internal production quality assurance (Annex IX). This classification applies to low-risk devices like undergarments and support garments.

Question 3

Are Medical Z’s devices listed in any public registries, and if so, which ones?

Accepted Answer

Yes, Medical Z’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This platform allows transparency regarding device manufacturers, their products, and regulatory compliance under EU oversight. Since the company operates in France, its listings fall under French regulatory authority within the broader EU framework.

Question 4

How are Medical Z’s devices classified under EU regulations, and what does that mean for their compliance?

Accepted Answer

Medical Z’s devices are classified as Class I under EU Medical Device Regulation (MDR). This classification applies to low-risk products like undergarments and support garments. For Class I devices, compliance is demonstrated through internal production quality assurance (Annex IX), ensuring manufacturing processes meet EU safety and performance standards without requiring third-party involvement.

Question 5

What distinguishes Medical Z’s products from standard undergarments, and why are they considered medical devices?

Accepted Answer

Medical Z’s products are designed with medical-grade materials and features tailored for post-procedural support or contouring, such as reinforced seams, gel inserts for pressure relief, or adjustable sizing. Unlike standard undergarments, these items are intended to aid recovery, reduce discomfort, or provide targeted support (e.g., post-liposuction or post-surgical wear), qualifying them as medical devices under EU definitions. Their classification as Class I reflects their low-risk nature while still serving a medical purpose.

Device	Model / Reference	Registries	Class	Status
T4 - Short Lipo Panty Blanc	S/004-222TK-0F0	EUDAMED	Class I	Active
T5 - Lipo Panty Coupe Taille Blanc	S/002-222TM-0F0	EUDAMED	Class I	Active
T6 - Combine Elegance Coolmax Noir Avec Trous	EC008-111TO-HOL	EUDAMED	Class I	Active
T6 - Lipo Panty Elegance Coolmax Haut Dos Blanc	EC035-222TO-0F0	EUDAMED	Class I	Active
T6 - Lipo Panty Chevilles Haut Blanc	S/018-222TO-0F0	EUDAMED	Class I	Active
T4 - Lipo Panty Elegance Coolmax Haut Dos Noir - Bbl - F.f. Par Zip	EC035-111TK-ZBL	EUDAMED	Class I	Active
T4 - Short Lipo Panty Elegance Coolmax Noir - Hbbl & F.f. Par Zip	EC006-111TK-ZHB	EUDAMED	Class I	Active
T6 - Drain Lipo Panty Haut Coolmax Noir Avec Enfile Panty - F.f. Par Zip	DR002-111TO-ZF0	EUDAMED	Class I	Active
Z Bra Noir 115-B	S/014-111OB-0F0	EUDAMED	Class I	Active
T2 - Lipo Panty Elegance Coolmax Noir - Bbl - F.f. Par Zip	EC001-111TG-ZBF	EUDAMED	Class I	Active
Z Bra Contenseur Blanc 90-A	S/024-222JA-0F0	EUDAMED	Class I	Active
T5 - Short Lipo Panty Elegance Coolmax Noir - Hbbl	EC006-111TM-HF0	EUDAMED	Class I	Active
T3 - Lipo Panty Elegance Coolmax H.coupe Genoux Blanc - F.f. Par Zip	EC003-222TI-ZFM	EUDAMED	Class I	Active
T6 - LIPO PANTY ELEGANCE COOLMAX HAUT DOS NOIR (-5 cm) - HBBL & F.F. PAR ZIP	EC035-111TO-ZHM	EUDAMED	Class I	Active
T2 - Ceinture Z Modele B Homme Noire / 201e00.032csb / 2111181	S/007-111TG-BH0	EUDAMED	Class I	Active
Z Bra Medical Reglable Zip Long Noir 105-A	S/034-111MA-0F0	EUDAMED	Class I	Active
T1 - Panty Lift Cheville Coolmax Noir Avec Trous Recouverts	EC018-111TE-BBL	EUDAMED	Class I	Active
T2 - Panty Lift Cheville Coolmax Noir	EC018-111TG-0F0	EUDAMED	Class I	Active
Sm - Panty Bras Coolmax Noir Avec Trous Recouverts Sur Mesure	EC016-111SM-BBL	EUDAMED	Class I	Active
Z Bra Noir 110-C	S/014-111NC-0F0	EUDAMED	Class I	Active
T4 - SHORT LIPO PANTY ELEGANCE COOLMAX HAUT DOS COUPE GENOU NOIR AVEC TROUS MODIFIE (-5 cm)	EC034-111TK-MHL	EUDAMED	Class I	Active
T3 - Combine Homme Blanc	S/016-222TI-0H0	EUDAMED	Class I	Active
T2 - Combine Elegance Coolmax Noir - Hbbl	EC008-111TG-HF0	EUDAMED	Class I	Active
T4+ - LIPO PANTY COUPE GENOUX NOIR MODIFIE (Fond Ferme)	S/003-111TL-0FM	EUDAMED	Class I	Active
T1 - Drain Lipo Panty Haut Coolmax Noir Avec Enfile Panty	DR002-111TE-0F0	EUDAMED	Class I	Active
T6 - Panty Lift Cheville Coolmax Noir Avec Trous	EC018-111TO-HOL	EUDAMED	Class I	Active
S - Ceinture Mousse Hd - Homme - Noir	S/203-111WS-0H0	EUDAMED	Class I	Active
FEUILLE MEDIGEL Z 30 cm * 40 cm (transparent) EPAISSEUR 3 MM	MG003-UD03Z-SFI	EUDAMED	Class I	Active
T1 - Lipo-Panty Noir Avec Trous	S/001-111TE-HOL	EUDAMED	Class I	Active
T2 - Romeo Blanc	EC038-222TG-0H0	EUDAMED	Class I	Active
T5 - CEINTURE HAUTE ELEGANCE COOLMAX BLANC MODIFE (Portes et Crochets)	EC012-222TM-0FC	EUDAMED	Class I	Active
T100-H25 - Ceinture Digi Z+ Avec Elastique Noire / 201e00.032csb / 2111181	S/038-111BJ-E25	EUDAMED	Class I	Active
T1 - Lipo Panty Homme Blanc Modifie	S/026-222TE-0H0	EUDAMED	Class I	Active
T150-H32 - Ceinture Digi Z+ Noire / 201e00.032csb+201e03.01 / 2111181	S/038-111BZ-E32	EUDAMED	Class I	Active
SM-H18 - CEINTURE DIGI Z BLANCHE SUR MESURE H18cm / 201E01.011CSA / 2127970	S/022-222SM-018	EUDAMED	Class I	Active
T6 - CEINTURE Z MODELE B HOMME NOIRE MODIFIEE (Côté et Entrejambe Par Crochets) / 201E00.032CSB / 2111181	S/007-111TO-0FC	EUDAMED	Class I	Active
T3 -pantalon Interimaire Fond Ouvert (66-76 Cm) (26"-30") Chair	BI073-333TG-0NR	EUDAMED	Class I	Active
T3 - Lipo Panty Elegance Coolmax Noir Avec Trous Recouverts	EC001-111TI-BBL	EUDAMED	Class I	Active
T5 - Combine Elegance Coolmax Chevilles Noir Avec Trous	EC010-111TM-HOL	EUDAMED	Class I	Active
Z Bra Noir 105-D	S/014-111MD-0F0	EUDAMED	Class I	Active
Sm - Combine Homme Noir - Hbbl Sur Mesure	EC037-111SM-HH0	EUDAMED	Class I	Active
T4+ - CEINTURE Z COOLMAX MODELE B FEMME NOIRE MODIFIE (-5 cm) / 201E00.032CSB / 2111181	EC014-111TL-SMT	EUDAMED	Class I	Active
Z Bra Noir 120-E	S/014-111PE-0F0	EUDAMED	Class I	Active
Z Bra Contenseur Noir 110-A	S/024-111NA-0F0	EUDAMED	Class I	Active
T4+ - Lipo Panty Chevilles Haut Blanc	S/018-222TL-0F0	EUDAMED	Class I	Active
T4+ - Lipo Panty Homme Coolmax Blanc	EC026-222TL-0H0	EUDAMED	Class I	Active
T4+ - Lipo Panty Elegance Coolmax Noir Avec Trous Recouverts	EC001-111TL-BBL	EUDAMED	Class I	Active
T3 - LIPO PANTY ELEGANCE COOLMAX H.COUPE GENOUX BLANC MODIFIE (Fond Ferme)	EC003-222TI-0FM	EUDAMED	Class I	Active
T7 - Ceinture Abdominale Blanche Homme / 201e00.032csb / 2111181	S/015-222TQ-0H0	EUDAMED	Class I	Active
T4+ - Short Lipo Panty Elegance Coolmax Haut Dos Coupe Genou Noir Avec Trous Recouverts	EC034-111TL-BBL	EUDAMED	Class I	Active

MEDICAL Z

What MEDICAL Z makes

Frequently asked questions

Information

Catalogue (3113)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities