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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 1 of 3

Device	Model / Reference	Registries	Class	Status
MICRO TUBES 1 mL (110)	9201	EUDAMED	Class A	Active
"manual Low Volume" Labels For Minicap Flex-Piercing (20)	9209	EUDAMED	Class A	Active
Cdt Samples Treatment Solution	2054	EUDAMED	Class A	Active
15 Wells Antisera Segment (10)	4397	EUDAMED	Class A	Active
Test Tubes (200)	9214	EUDAMED	Class A	Active
Hydragel Barcodes Reader	1080	EUDAMED	Class A	Active
Capillarys 3 Dbs Microplates	2578	EUDAMEDFDA UDI	Class A	Active
Segment Holder (dm)	1256	EUDAMED	Class A	Active
Capillarys 3 & Mc Switch Rack For Urine (1)	1378	EUDAMED	Class A	Active
Hydragel Applicators 6 (10)	4196	EUDAMED	Class A	Active
isatuximab CONTROL	4764	EUDAMEDFDA UDI	Class A	Active
Filter Paper Combs 12 Teeth / 10 (5)	4191	EUDAMED	Class A	Active
Urine Profil(e) Accessories (dm)	1274	EUDAMED	Class A	Active
Antisera Adapter 9 Positions For Assist	1650	EUDAMED	Class A	Active
Hydrasys 2 If / Bj (hr) Accessories (sm)	1254	EUDAMED	Class A	Active
Capillarys 3 Octa	1245	EUDAMED	Class A	Active
Hydrashift 2/4 Accessories	1251	EUDAMED	Class A	Active
Capillarys 3 & Mc Sample Racks (70)	1359	EUDAMED	Class A	Active
Colored Reference Guides (dm)	1257	EUDAMED	Class A	Active
Hydrasys Container (black Cap) 0.5 L	1283	EUDAMED	Class A	Active
Hydrasys 2 Scan Focusing	1202	EUDAMED	Class A	Active
Capillarys 3 & Mc Switch Rack For Protein(e) 6 (1)	1381	EUDAMED	Class A	Active
Clear Dilution Segments (90)	2080	EUDAMED	Class A	Active
CAPILLARYS 3 & MC SWITCH RACK FOR HbA1c (1)	1383	EUDAMED	Class A	Active
Minicap Hemoglobin(e) Kit, Model 2207, 2227	K082227	FDA 510(k)	Class II	Active
Sebia Capillarys Hemoglobin(e) With Capillarys 2	K112491	FDA 510(k)	Class II	Active
Hydragel Protein(e) Kit	K951536	FDA 510(k)	Class I	Active
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2	K210623	FDA 510(k)	Class II	Active
Capillarys Immunotyping, Capillarys 2 Instrument, It/If Control, Capillarys 2 Flex Piercing Instrument	K130500	FDA 510(k)	Class I	Active
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument	K232027	FDA 510(k)	Class II	Active
Capillarys Neonat Hb (pn 2006)	K091283	FDA 510(k)	Class II	Active
Hydragel 7 Lipoprotein(e), Pn 4114 & Hydragel Lipoprotein(e) 15/30 Pn 4134	K022053	FDA 510(k)	Class I	Active
Capillary's Hemoglobin(e) (pn 2007)	K052291	FDA 510(k)	Class II	Active
It/If Control	K101863	FDA 510(k)	Class I	Active
Gelscan, Model 1206	K100307	FDA 510(k)	Class II	Active
Normal And Hypergamma Control Serum	K040925	FDA 510(k)	Class I	Active
Minicap Immunotyping, Model: 2300	K082388	FDA 510(k)	Class II	Active
CAPI 3 Immunotyping, Capillarys 3 Tera	K192095	FDA 510(k)	Class II	Active
Hydragel Iso-Pal K20 (pn 3022); Hydragel 7 Iso-Pal (pn 4112); Hydragel 15 Iso-Pal (pn 4132)	K011113	FDA 510(k)	Class II	Active
Capi 3 Hemoglobin(e)	K180762	FDA 510(k)	Class II	Active
Hydragel 18 A1at Isofocusing Kit (pn 4356)	K063498	FDA 510(k)	Class II	Active
Capi 3 Immunotyping, Capillarys 3 Tera, It/If Control	K161928	FDA 510(k)	Class II	Active
Capillarys Immunotyping, Model 2100	K082085	FDA 510(k)	Class II	Active
Capillarys Hemoglobin, Capillarys Flex Piercing System	K112550	FDA 510(k)	Class II	Active
Capillarys Hemoglobin Hba1c Capillarys 2 Flex Piercing Capillarys Hba1c Controls Capillarys Hba1c C	K122101	FDA 510(k)	Class II	Active
Hyragel Iso-Ldh Kit/Hydragel 15 Iso-Ldh Kit	K970477	FDA 510(k)	Class II	Active
Minicap Hb A1c, Minicap Flex-Piercing, Hb A1c Capillarys Controls, Hba1c Capillarys Calibrators	K133344	FDA 510(k)	Class II	Active
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)	K162281	FDA 510(k)	Class II	Active
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2	K231601	FDA 510(k)	Class II	Active
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING	K143483	FDA 510(k)	Class II	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