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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 (209)

Page 2 of 5

Device	Model / Reference	Registries	Class	Status
Irrigation and/or aspiration lines	Y1500070	EUDAMED	Class IIa	Active
Infusion Lines	SM000010B	EUDAMED	Class IIa	Active
Smoke Evacuation Lines	20323-003	EUDAMED	Class I	Active
Dental Tubing lines	100-G	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	1188	EUDAMED	Class IIa	Active
Dental Tubing lines	100-G	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	20325-010	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	CAN2505GL	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	1502152	EUDAMED	Class IIa	Active
Infusion Lines	SM000082	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	SI.10.330.005	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-022	EUDAMED	Class IIa	Active
Infusion Lines	SM000080	EUDAMED	Class IIa	Active
Dental Tubing lines	Y900197	EUDAMED	Class IIa	Active
Infusion Lines	SM000011B	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	20325-011	EUDAMED	Class IIa	Active
Dental Tubing lines	Y1003915	EUDAMED	Class IIa	Active
Cuff Pressure Tube	282016	EUDAMED	Class I	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-009	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	01-Geu-Ext	EUDAMED	Class IIa	Active
Vacuum line with hydrophobic filter	EBT01615	EUDAMED	Class I	Active
TRACOE Connection Tube with check valve	ODG0702SC167	EUDAMED	Class I	Active
Infusion Lines	SM000076	EUDAMED	Class IIa	Active
Infusion Lines	SM000081	EUDAMED	Class IIa	Active
Dental Tubing lines	Y900114	EUDAMED	Class IIa	Active
Infusion Lines	SM000021	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	02-IA-Phako	EUDAMED	Class IIa	Active
Infusion Lines	SM000011ARB	EUDAMED	Class IIa	Active
Infusion Lines	SM000095	EUDAMED	Class IIa	Active
Infusion Lines	SM000021	EUDAMED	Class IIa	Active
Infusion Lines	SM000032	EUDAMED	Class IIa	Active
Dental Tubing lines	1500984-005	EUDAMED	Class IIa	Active
Smoke Evacuation Lines	WA95007A	EUDAMED	Class I	Active
Smoke Evacuation Lines	20323-006	EUDAMED	Class I	Active
General Surgery Tubing Sets	FRIGF2	EUDAMED	Class IIa	Active
Infusion Lines	SM000012ARB	EUDAMED	Class IIa	Active
Infusion Lines	SM000072	EUDAMED	Class IIa	Active
Infusion Lines	SM000093	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	CAN10	EUDAMED	Class IIa	Active
Infusion Lines	X100-AS	EUDAMED	Class IIa	Active
Dental Tubing lines	1501738-005	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-009	EUDAMED	Class IIa	Active
Infusion Lines	SM000081	EUDAMED	Class IIa	Active
Infusion Lines	SM000012B	EUDAMED	Class IIa	Active
Dental Tubing lines	100-F43	EUDAMED	Class IIa	Active
Dental Tubing lines	1500984-010P	EUDAMED	Class IIa	Active
Infusion Lines	ODG6542ST177	EUDAMED	Class IIa	Active
Infusion Lines	SM000091	EUDAMED	Class IIa	Active
Infusion Lines	SM000031	EUDAMED	Class IIa	Active
Infusion Lines	SFX-103Y	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Promepla Group S.à r.l. LU

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