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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 1 of 5

Device	Model / Reference	Registries	Class	Status
Infusion Lines	SM000019	EUDAMED	Class IIa	Active
Smoke Evacuation Lines	20323-011	EUDAMED	Class I	Active
Irrigation and/or aspiration lines	Z1296001	EUDAMED	Class IIa	Active
Infusion Lines	SM000023	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-009	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	1100037	EUDAMED	Class IIa	Active
Infusion Lines	SM000010B	EUDAMED	Class IIa	Active
Infusion Lines	SM000076	EUDAMED	Class IIa	Active
Infusion Lines	SM000032	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	Y1500070	EUDAMED	Class IIa	Active
Dental Tubing lines	1501635-010	EUDAMED	Class IIa	Active
Dental Tubing lines	C823752	EUDAMED	Class IIa	Active
Dental Tubing lines	20000655	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	CAN2505DP	EUDAMED	Class IIa	Active
Infusion Lines	SM000072	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	Z1298001	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-002	EUDAMED	Class IIa	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-022	EUDAMED	Class IIa	Active
Infusion Lines	SM000011B	EUDAMED	Class IIa	Active
Infusion Lines	X100-AS	EUDAMED	Class IIa	Active
Dental Tubing lines	Y900113	EUDAMED	Class IIa	Active
Infusion Lines	SM000010	EUDAMED	Class IIa	Active
Infusion Lines	SM000020	EUDAMED	Class IIa	Active
Smoke Evacuation Lines	20323-003	EUDAMED	Class I	Active
Irrigation and/or aspiration lines	1502152	EUDAMED	Class IIa	Active
Dental Tubing lines	1501738-005	EUDAMED	Class IIa	Active
Dental Tubing lines	100-F63	EUDAMED	Class IIa	Active
Infusion Lines	X150-00	EUDAMED	Class IIa	Active
General Surgery Tubing Sets	FRIGF2	EUDAMED	Class IIa	Active
Irrigation and/or aspiration lines	20325-010	EUDAMED	Class IIa	Active
Infusion Lines	SM000077	EUDAMED	Class IIa	Active
Dental Tubing lines	1501635-010	EUDAMED	Class IIa	Active
Infusion Lines	SM000011	EUDAMED	Class IIa	Active
Infusion Lines	SM000010	EUDAMED	Class IIa	Active
Dental Tubing lines	1501738-010	EUDAMED	Class IIa	Active
Infusion Lines	SM000023	EUDAMED	Class IIa	Active
Smoke Evacuation Lines	20323-011	EUDAMED	Class I	Active
Ophthalmology irrigation/aspiration tubing lines	W-13-003	EUDAMED	Class IIa	Active
Dental Tubing lines	100-F63	EUDAMED	Class IIa	Active
Infusion Lines	SM000011	EUDAMED	Class IIa	Active
Infusion Lines	SM000080	EUDAMED	Class IIa	Active
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

Related Companies

Authorised Representatives

Promepla Group S.à r.l. LU

Importers

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Notified Bodies

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Authorities

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