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SEBIA

France·FR-MF-000003520

Last updated September 17, 2026

Information

Country: France
Address: Parc Technologique Léonard de Vinci, Lisses, France
Website: www.sebia.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +33 1 69 89 83 31
PRRC Contact: Arnaud COLLIN
EUDAMED SRN: FR-MF-000003520
FDA FEI Number: 6387
DUNS Number: 276801933

Catalogue (148)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Capillarys 3 Tera	1246	EUDAMED	Class A	Active
METAL WEIGHT 2.3 kg	1654	EUDAMED	Class A	Active
Hydrasys Container (green Cap) 5 L	1286	EUDAMED	Class A	Active
Yellow Dilution Segments (70)	2079	EUDAMED	Class A	Active
CAPIprotect	2061	EUDAMED	Class A	Active
Hydrasys Container Kit	1282	EUDAMED	Class A	Active
MINICAP FLEX-PIERCING CENTERING RING FOR TUBES 11 mm (27)	1612	EUDAMED	Class A	Active
MINICAP Hb A1c	2215	EUDAMEDFDA UDI	Class C	Active
Capillarys 3 & Mc Switch Rack For Immunotyping (1)	1382	EUDAMED	Class A	Active
Hydrasys 2 Applicator Carrier	1299	EUDAMED	Class A	Active
Capillarys 3 & Mc Switch Rack For Cdt (1)	1376	EUDAMED	Class A	Active
External Accessories For Waste Disposal Of Capillarys 3	1389	EUDAMED	Class A	Active
Hydrasys Wash Solution (10)	4541	EUDAMEDFDA UDI	Class A	Active
Tubes And Caps For Controls (500)	9205	EUDAMED	Class A	Active
Assist	1218	EUDAMED	Class A	Active
Hb A1c CAPILLARY CALIBRATORS (5x2)	4756	EUDAMED	Class C	Active
CAPI 3 REAGENT CUPS (24 x 14)	2582	EUDAMED	Class A	Active
Csf Isofocusing Dynamic Mask Guide	1236	EUDAMED	Class A	Active
Gel Barcode Labels (500)	9206	EUDAMED	Class A	Active
Hydragel Applicators 18 (10)	4198	EUDAMED	Class A	Active
Dynamic Mask	1255	EUDAMED	Class A	Active
Hydragel Applicators 15 (10)	4199	EUDAMED	Class A	Active
Hydrasys Container (red Cap) 0.5 L	1284	EUDAMED	Class A	Active
Thick Filter Papers / 10 (6)	4194	EUDAMED	Class A	Active
Dialysis System (24)	9200	EUDAMED	Class A	Active
Capillarys 3 Capiclean	2060	EUDAMEDFDA UDI	Class A	Active
Hydrasys 9 If Accessories (sm)	1265	EUDAMED	Class A	Active
Dry Storage Chamber	1271	EUDAMED	Class A	Active
If Sample Diluent	4588	EUDAMED	Class A	Active
Hydrasys 2 Gel Holder	1297	EUDAMED	Class A	Active
Metal Weight 1.8kg	1652	EUDAMED	Class A	Active
Hydrasys 2 Strip Carrier	1298	EUDAMED	Class A	Active
Capi 3 Bins For Used Reagent Cups (5)	2581	EUDAMED	Class A	Active
Hydrasys Csf Accessories (dm)	1259	EUDAMED	Class A	Active
HYDRASYS 11 von WILLEBRAND MULTIMERS ACCESSORIES	1653	EUDAMED	Class A	Active
Destaining Solution (10)	4540	EUDAMEDFDA UDI	Class A	Active
Capiclean	2058	EUDAMEDFDA UDI	Class A	Active
18 Wells Antisera Segment (10)	4398	EUDAMED	Class A	Active
Hydrashift Green Applicators 15 (10)	4195	EUDAMED	Class A	Active
Minicap Reagent Cups / 125 (3)	2281	EUDAMED	Class A	Active
HYDRASHIFT 2/4 daratumumab (20 TESTS)	4639	EUDAMEDFDA UDI	Class A	Active
Capillarys 3 & Mc Low Volumes Racks (5)	1364	EUDAMED	Class A	Active
Capillarys 3 & Mc Calibrators/Controls Rack (1)	1362	EUDAMED	Class A	Active
Amidoblack Staining Solution	4554	EUDAMEDFDA UDI	Class A	Active
CAPI 3 Hb A1c	2515	EUDAMEDFDA UDI	Class C	Active
Filters For Capillarys / Minicap Solutions (10)	2085	EUDAMED	Class A	Active
"automatic Low Volume" Labels For Minicap Flex-Piercing (20)	9208	EUDAMED	Class A	Active
Hydragel Applicators 7 (10)	4197	EUDAMED	Class A	Active

Related Companies

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 29, 2006	Z-0073-2007	—	terminated	The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Sebia, Inc. US