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CeramOptec GmbH

Germany·DE-MF-000005607

Last updated September 17, 2026

Information

Country: Germany
Address: 44, Siemensstraße, Bonn, Germany
Website: www.ceramoptec.com or www.biolitec.de
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +49 228 97 967 0
PRRC Contact: —
EUDAMED SRN: DE-MF-000005607
FDA FEI Number: 3003340844
DUNS Number: 325264513

Catalogue (67)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Orthopedic Kit	502200835	EUDAMED	Class IIa	Active
Proctology Kit	503100261-1	EUDAMED	Class IIa	Active
ELVeS® Kit	503100158-1	EUDAMED	Class IIa	Active
Bare Fiber	503200740	EUDAMED	Class IIa	Active
Bare Fiber	503200165	EUDAMED	Class IIa	Active
Proctology	502400505	EUDAMED	Class IIa	Active
Bare Fiber	503500520	EUDAMED	Class IIa	Active
LaEvita	400500420	EUDAMED	Class I	Active
Proctology	503400505	EUDAMED	Class IIa	Active
Bare Fiber	500200790	EUDAMED	Class IIa	Active
Leonardo Duster	K250504	FDA 510(k)	Class II	Active
Leonardo Mini Blue	K210951	FDA 510(k)	Class II	Active
Bare Fiber	501805745	EUDAMED	Class IIa	Active
Bare Fiber	503500500	EUDAMED	Class IIa	Active
Bare Fiber	503300410	EUDAMED	Class IIa	Active
Bare Fiber	503200765	EUDAMED	Class IIa	Active
Bare Fiber	502200884	EUDAMED	Class IIa	Active
ELVeS® smart, Pullback device	L-ElvesSmart	EUDAMED	Class I	Active
Proctology	503100200	EUDAMED	Class IIa	Active
Bare Fiber	503200290	EUDAMED	Class IIa	Active
Bare Fiber	503201919	EUDAMED	Class IIa	Active
Bare Fiber	501200315	EUDAMED	Class IIa	Active
Bare Fiber	503500530	EUDAMED	Class IIa	Active
Proctology	501805200	EUDAMED	Class IIa	Active
Bare Fiber	503200175	EUDAMED	Class IIa	Active
Bare Fiber	501200391	EUDAMED	Class IIa	Active
Bare Fiber	503200100	EUDAMED	Class IIa	Active
Leonardo® Bonsai 1470	SLB1470nm15W	EUDAMED	Class IIb	Active
Bare Fiber	503200115	EUDAMED	Class IIa	Active
Bare Fiber	500200792	EUDAMED	Class IIa	Active
LaEvita	400500430	EUDAMED	Class I	Active
Proctology	503805200	EUDAMED	Class IIa	Active
Bare Fiber	503200125	EUDAMED	Class IIa	Active
Bare Fiber	501200744	EUDAMED	Class IIa	Active
Bare Fiber	500200789	EUDAMED	Class IIa	Active
Coupling Fiber	501200390	EUDAMED	Class I	Active
Bare Fiber	503200150	EUDAMED	Class IIa	Active
Bare Fiber	503200800	EUDAMED	Class IIa	Active
Bare Fiber	503200105	EUDAMED	Class IIa	Active
Bare Fiber	503200160	EUDAMED	Class IIa	Active
Bare Fiber	501201919	EUDAMED	Class IIa	Active
Bare Fiber	505200920	EUDAMED	Class IIa	Active
Bare Fiber	503200744	EUDAMED	Class IIa	Active
Proctology	503100260	EUDAMED	Class IIa	Active
Proctology	503200260	EUDAMED	Class IIa	Active
Bare Fiber	503200110	EUDAMED	Class IIa	Active
Bare Fiber	503500502	EUDAMED	Class IIa	Active
Proctology	501100260	EUDAMED	Class IIa	Active
Coupling Fiber	503200390	EUDAMED	Class I	Active
Proctology	501100250	EUDAMED	Class IIa	Active

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FDA Establishments (1)

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

Ceram Optec, Inc. US