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Promepla SAM

Monaco·MC-MF-000015769

Last updated September 18, 2026

About

Discover Promepla Group, your trusted contract design manufacturing partner for single-use plastic medical devices and components. From cleanroom manufacturing and assembly to customised medical solutions, we support healthcare and biopharma industries with end-to-end expertise, innovation, and quality-driven production.

From the manufacturer's own website. Source

Information

Country: Monaco
Address: 9, Avenue Albert II, Monaco, Monaco
Website: www.promepla.com
LinkedIn: linkedin.com/company/promepla
Facebook: —
Email: [email protected]
Phone: +37797984232
PRRC Contact: Kim HERBERT
EUDAMED SRN: MC-MF-000015769
FDA FEI Number: —
DUNS Number: —

Catalogue (202)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Infusion Lines	SM000010	EUDAMED	Class IIa	Active
Infusion Lines	SM000031	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	Y1500070	EUDAMED	Class IIa	Active
Infusion Lines	SM000078	EUDAMED	Class IIa	Active
Infusion Lines	SM000092	EUDAMED	Class IIa	Active
Infusion Lines	SM000093	EUDAMED	Class IIa	Active
Infusion Lines	SM000021	EUDAMED	Class IIa	Active
Infusion Lines	X100-AS	EUDAMED	Class IIa	Active
Embryo Transfer Set	EBT0018-EKT-NV	EUDAMED	Class I	Active
Infusion Lines	SM000011ARB	EUDAMED	Class IIa	Active
Infusion Lines	SM000011ARB	EUDAMED	Class IIa	Active
Infusion Lines	SFX-102Y	EUDAMED	Class IIa	Active
Infusion Lines	ODG6542ST177	EUDAMED	Class IIa	Active
Dental Tubing lines	Y900197	EUDAMED	Class IIa	Active
Infusion Lines	SM000074	EUDAMED	Class IIa	Active
Dental Tubing lines	1500984-010P	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-017	EUDAMED	Class IIa	Active
Dental Tubing lines	Z263002	EUDAMED	Class IIa	Active
Dental Tubing lines	Y900114	EUDAMED	Class IIa	Active
Dental Tubing lines	100-F43	EUDAMED	Class IIa	Active
Dental Tubing lines	1501738-010	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	1100037	EUDAMED	Class IIa	Active
Cuff Pressure Tube	282016	EUDAMED	Class I	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-004	EUDAMED	Class IIa	Active
General Surgery Tubing Sets	WA95005A	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-019	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	ONG09499ST254	EUDAMED	Class IIa	Active
Infusion Lines	SM000022	EUDAMED	Class IIa	Active
Embryo Transfer Set	EBT0018-EKT-NV	EUDAMED	Class I	Active
Infusion Lines	X150-00	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-004	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	Z1298001	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	1188	EUDAMED	Class IIa	Active
Infusion Lines	SM000010B	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-004	EUDAMED	Class IIa	Active
Dental Tubing lines	1501738-005	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	1100037	EUDAMED	Class IIa	Active
Infusion Lines	SM000078	EUDAMED	Class IIa	Active
TRACOE Connection Tube with check valve	ODG0702SC167	EUDAMED	Class I	Active
Irrigation and/or aspiration lines	CAN25010	EUDAMED	Class IIa	Active
Infusion Lines	SM000074	EUDAMED	Class IIa	Active
Vacuum line with hydrophobic filter	EBT01615	EUDAMED	Class I	Active
Infusion Lines	SM000019	EUDAMED	Class IIa	Active
Infusion Lines	SM000073	EUDAMED	Class IIa	Active
Infusion Lines	SM000019	EUDAMED	Class IIa	Active
Infusion Lines	SM000020	EUDAMED	Class IIa	Active
Infusion Lines	SM000075	EUDAMED	Class IIa	Active
Infusion Lines	SM000095	EUDAMED	Class IIa	Active
Hunter Sterile Pasteur Bulb	HPB-100	EUDAMED	Class I	Active
Embryo Transfer Set	EBT00118-3P	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

Promepla Group S.à r.l. LU

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