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
T5 - Ceinture Z Modele A Femme Noire / 201e00.031csb / 2168123	S/009-111TM-AF0	EUDAMED	Class I	Active
Z Bra Contenseur Noir 90-D	S/024-111JD-0F0	EUDAMED	Class I	Active
Soutien Gorge Reglable S/035 Blanc 90-B	S/035-222JB-0F0	EUDAMED	Class I	Active
T4+ - Lipo Panty Elegance Coolmax Chevilles Coupe Taille Blanc	EC005-222TL-0F0	EUDAMED	Class I	Active
Enfile Vetements (manche) Taille M Pour Vetement T2 - T3	AC010-516MO-000	EUDAMED	Class I	Active
T7 - LIPO PANTY ELEGANCE COOLMAX HAUT NOIR MODIFIE (Fond Ferme) AVEC TROUS	EC002-111TQ-HOF	EUDAMED	Class I	Active
T120-H25 - Ceinture Digi Z Sans Elastique Blanche / 201e00.032csb / 2111181	S/022-222BP-025	EUDAMED	Class I	Active
DIGITUB Z Fermé transparent T1 EPAISSEUR 2, 5 MM	MG002-TE02C-SFF	EUDAMED	Class I	Active
FEUILLE MEDIGEL Z 20 cm * 20 cm (sur tissu) STANDARD EPAISSEUR 5 MM	MG003-UC05Z-STI	EUDAMED	Class I	Active
Z Bra Contenseur Noir 100-A	S/024-111LA-0F0	EUDAMED	Class I	Active
T4 - CEINTURE Z FEMME HAUTE FERMETURE CENTRALE NOIRE MODIFIEE (-3cm) / 201E00.032CSB / 2111181	S/032-111TK-0FM	EUDAMED	Class I	Active
T1 - LIPO PANTY ELEGANCE COOLMAX NOIR MODIFIE (Fond Ferme)	EC002-111TE-0FM	EUDAMED	Class I	Active
Sm - Short Lipo Panty Blanc S/Mesure	S/004-222SM-0F0	EUDAMED	Class I	Active
Sm - Lipo Panty Blanc Sur Mesure	S/001-222SM-0F0	EUDAMED	Class I	Active
T4 - LIPO PANTY ELEGANCE COOLMAX HAUT DOS NOIR - BBL - (-5 cm) - F.F. PAR ZIP	EC035-111TK-ZMB	EUDAMED	Class I	Active
Sm - Lipo Panty Elegance Coolmax Chevilles Coupe Taille Noir - F.f. Par Zip - Sur Mesure	EC005-111SM-ZF0	EUDAMED	Class I	Active
T4 - Short Lipo Panty Elegance Coolmax Haut Dos Coupe Genou Noir	EC034-111TK-0F0	EUDAMED	Class I	Active
T7 - SHORT LIPO PANTY ELEGANCE COOLMAX HAUT DOS COUPE GENOU NOIR MODIFIE (-5 cm)	EC034-111TQ-0FM	EUDAMED	Class I	Active
T4 - Ceinture Abdominale Haute Noire	S/030-111TK-0F0	EUDAMED	Class I	Active
T2 - Veste Romeo Dos Ferme - Epaules Reglables - Bleu	EC049-506TG-0H0	EUDAMED	Class I	Active
T0 - Ceinture Z Coolmax Femme Haute Fermeture Centrale Blanche / 201e00.032csb / 2111181	EC032-222TC-0F0	EUDAMED	Class I	Active
T7 - Combine Homme Mollet Noir	EC043-111TQ-0H0	EUDAMED	Class I	Active
T4+ - Drain Lipo Panty Haut Coolmax Blanc Avec Enfile Panty	DR002-222TL-0F0	EUDAMED	Class I	Active
T1 - Lipo Panty Elegance Coolmax Haut Dos Noir	EC035-111TE-0F0	EUDAMED	Class I	Active
T4 - LIPO PANTY ELEGANCE COOLMAX HAUT DOS NOIR AVEC TROUS RECOUVERTS MODIFIE (-5 cm)	EC035-111TK-MBL	EUDAMED	Class I	Active
Z Bra Confort Chair 110-A	S/052-333NA-0F0	EUDAMED	Class I	Active
T6 - Lipo Panty Elegance Coolmax Haut Noir - Hbbl	EC002-111TO-HF0	EUDAMED	Class I	Active
T5 - Combine Elegance Coolmax Chevilles Noir - Hbbl	EC010-111TM-HF0	EUDAMED	Class I	Active
T5 - Ceinture Basse Elegance Coolmax Noir	EC011-111TM-0F0	EUDAMED	Class I	Active
SM-H32 - CEINTURE DIGI Z NOIRE SUR MESURE H32cm / 201E01.013CSA / 2119870	S/022-111SM-032	EUDAMED	Class I	Active
T3 - Manchon Coolmax Noir	EC044-111TI-0F0	EUDAMED	Class I	Active
T4+ - Drain Ceinture Z Coolmax Femme Haute Fermeture Centrale Noire	DR032-111TL-0F0	EUDAMED	Class I	Active
T4+ - Combine Elegance Coolmax Coupe Genoux Noir - Hbbl	EC009-111TL-HF0	EUDAMED	Class I	Active
Z Bra Confort Noir 110-C	S/052-111NC-0F0	EUDAMED	Class I	Active
T7 -gilet Interimaire Manche Courte (86-104 Cm) (34"-41") Noir	BI067-111TQ-0NR	EUDAMED	Class I	Active
Sm - Lipo Bras Coolmax Noir Sur Mesure	EC042-111SM-0F0	EUDAMED	Class I	Active
T6 - Lipo Panty Elegance Coolmax Chevilles Coupe Taille Noir Avec Trous Recouverts	EC005-111TO-BBL	EUDAMED	Class I	Active
T5 - SHORT LIPO PANTY ELEGANCE COOLMAX NOIR MODIFIE (Fond Ferme) AVEC TROUS RECOUVERTS	EC006-111TM-BBF	EUDAMED	Class I	Active
Z Bra Confort Chair 90-C	S/052-333JC-0F0	EUDAMED	Class I	Active
T4 - Lipo Panty Elegance Coolmax Haut Noir - Bbl - F.f. Par Zip	EC002-111TK-ZBF	EUDAMED	Class I	Active
T5 - Ceinture Elegance Coolmax Haut Dos Fermeture Centrale Noire	EC033-111TM-0F0	EUDAMED	Class I	Active
T6 - Lipo Panty Elegance Coolmax Chevilles Coupe Taille Noir - Hbbl & F.f. Par Zip	EC005-111TO-ZHB	EUDAMED	Class I	Active
Z Bra Noir 85-B	S/014-111IB-0F0	EUDAMED	Class I	Active
T6 - Lipo Panty Chevilles Coupe Taille Noir Avec Trous	S/019-111TO-HOL	EUDAMED	Class I	Active
T2 - LIPO PANTY ELEGANCE COOLMAX HAUT DOS NOIR - BBL - (-5 cm) - F.F. PAR ZIP	EC035-111TG-ZMB	EUDAMED	Class I	Active
MENTONNIERE GEL Z Enfant	MG005-EN03Z-0EN	EUDAMED	Class I	Active
Z Bra Contenseur Noir 85-C	S/024-111IC-0F0	EUDAMED	Class I	Active
T2 - Short Lipo Panty Noir Avec Trous Recouverts	S/004-111TG-BBL	EUDAMED	Class I	Active
T2 - Short Lipo Panty Blanc	S/004-222TG-0F0	EUDAMED	Class I	Active
T5 - Ceinture Z Femme Haute Fermeture Centrale Blanche / 201e00.032csb / 2111181	S/032-222TM-0F0	EUDAMED	Class I	Active

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