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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Hydrasys Iso-Ldh, Iso-Pal, Chol Accessories	1261	EUDAMED	Class A	Active
Clean Protect	2059	EUDAMEDFDA UDI	Class A	Active
Hydrasys Lipoprotein(e)s Accessories	1263	EUDAMED	Class A	Active
Capillarys 3 & Mc Capillary Blood Racks (5)	1363	EUDAMED	Class A	Active
Scan Control Film	1949	EUDAMED	Class A	Active
Minicap Flex-Piercing	1232	EUDAMED	Class A	Active
Hydrasys A1at Isofocusing Accessories	1253	EUDAMED	Class A	Active
Acid Violet Staining Solution	4553	EUDAMEDFDA UDI	Class A	Active
Blue Dilution Segments (70)	2083	EUDAMED	Class A	Active
Filter Paper Combs 6 Teeth / 10 (5)	4190	EUDAMED	Class A	Active
Capillarys 3 & Mc Switch Rack For Hemoglobin(e) (1)	1373	EUDAMED	Class A	Active
Fluidil	4587	EUDAMEDFDA UDI	Class A	Active
Green Dilution Segments (90)	2081	EUDAMED	Class A	Active
Hydrasys Universal Gel Holder	1278	EUDAMED	Class A	Active
HYDRASYS 5 von WILLEBRAND MULTIMERS ACCESSORIES	1651	EUDAMED	Class A	Active
CAPILLARYS Hb A1c	2015	EUDAMEDFDA UDI	Class C	Active
Capillarys Humidity Chamber	1294	EUDAMED	Class A	Active
daratumumab CONTROL	4765	EUDAMEDFDA UDI	Class A	Active
Capillarys / Minicap Wash Solution (2)	2052	EUDAMEDFDA UDI	Class A	Active
Thin Filter Papers / 10 (6)	4193	EUDAMED	Class A	Active
HYDRASHIFT 2/4 isatuximab (40 TESTS)	4642	EUDAMEDFDA UDI	Class A	Active
Urine Profil(e) Mask (sm)	1273	EUDAMED	Class A	Active
A1c/Ce Low Volume Sample Collection Tube	9216	EUDAMED	Class A	Active
Minicap Flex-Piercing Capiclean	2251	EUDAMEDFDA UDI	Class A	Active
Gelscan	1206	EUDAMED	Class A	Active
Hydrasys 1 If / 1 Bence Jones Accessories (sm)	1267	EUDAMED	Class A	Active
Capi 3 Urine	2513	EUDAMEDFDA UDI	Class A	Active
Tubes And Caps For Controls (20)	9202	EUDAMED	Class A	Active
Hydrasys Container (white Cap) 5 L	1285	EUDAMED	Class A	Active
Capillarys 3 & Mc Sample Racks (10)	1369	EUDAMED	Class A	Active
Humidity Chamber	1270	EUDAMED	Class A	Active
Capillarys / Minicap Urine	2013	EUDAMED	Class A	Active
Hydrasys 9 Bence Jones Accessories (sm)	1266	EUDAMED	Class A	Active
Hb A1c CAPILLARY CALIBRATORS (2)	4755	EUDAMED	Class C	Active
Hydrasys Csf Accessories (sm)	1262	EUDAMED	Class A	Active
Capillarys 3 & Mc Shutdown Rack (1)	1391	EUDAMED	Class A	Active
Hydrasys Iso-Ck Accessories	1264	EUDAMED	Class A	Active
Capillarys 3 Wash Solution (1)	2062	EUDAMEDFDA UDI	Class A	Active
Filter Paper Combs 18 Teeth / 10 (5)	4192	EUDAMED	Class A	Active
A1c/Ce - Capillary Blood Sample Kit (a)	9212	EUDAMED	Class A	Active
Capillarys 3 & Mc Switch Rack For Immunotyping Urine (1)	1379	EUDAMED	Class A	Active
Rack Conveyor Capillarys 3	1250	EUDAMED	Class A	Active
Dtt Diluent (if / It)	4589	EUDAMEDFDA UDI	Class A	Active
Hydraplus / Assist Sponge Kit	1287	EUDAMED	Class A	Active
Capillarys / Minicap Barcodes Reader	1079	EUDAMED	Class A	Active
Tube Loader Capillarys 3	1249	EUDAMED	Class A	Active
Hydrasys Csf Isofocusing Accessories	1258	EUDAMED	Class A	Active
NNHb WHITE DILUTION SEGMENTS (2x110)	2078	EUDAMED	Class A	Active
Hydrasys If Accessories (sm)	1260	EUDAMED	Class A	Active
Applicator Barcode Labels (500)	9207	EUDAMED	Class A	Active

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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