Is this your brand? Sign in to claim ownership.

Rigicon, Inc.

United States·US-MF-000027758

Last updated September 17, 2026

Information

Country: United States
Address: 2805 Veterans Highway, Ronkonkoma, NY, 11779
Website: rigicon.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 888 202 9790
PRRC Contact: Merve Can
EUDAMED SRN: US-MF-000027758
FDA FEI Number: 3013987875
DUNS Number: 045247683

Catalogue (43)

Device	Model / Reference	Registries	Class	Status
Testi10™	TESTIS-L	EUDAMED	Class IIb	Active
RigiSoft™	RGS1009	EUDAMED	Class IIb	Active
Testi10™	TESTIF-S	EUDAMED	Class IIb	Active
RigiSoft™	RGS1011	EUDAMED	Class IIb	Active
Testi10™	TESTIS-M	EUDAMED	Class IIb	Active
Testi10™	TESTISF-XS	EUDAMED	Class IIb	Active
Testi10™	TESTISF-L	EUDAMED	Class IIb	Active
RigiSoft™	RGS1014	EUDAMED	Class IIb	Active
Testi10™	TESTIS-XS	EUDAMED	Class IIb	Active
RigiSoft™	RGS1012	EUDAMED	Class IIb	Active
Testi10™	TESTISF-M	EUDAMED	Class IIb	Active
RigiSoft™	RGS1010	EUDAMED	Class IIb	Active
Testi10™	TESTIF-M	EUDAMED	Class IIb	Active
RigiSoft™	RGS1013	EUDAMED	Class IIb	Active
Testi10™	TESTIF-XL	EUDAMED	Class IIb	Active
Rigicon HL Dilator 09 – 10 mm	RSUD-0910	FDA UDI	Class I	Active
Rigi10	RG1012	FDA UDI	Class II	Active
Rigicon Stainless Steel Furlow Insertion Tool	RSSF-1000	FDA UDI	Class I	Active
Rigicon Dilatom™	11-12 MM	FDA UDI	Class I	Active
Rigicon Dilatom™	07-08 MM	FDA UDI	Class I	Active
Rigi10	RG1011	FDA UDI	Class II	Active
Rigicon Dilatom™	10-12 MM	FDA UDI	Class I	Active
Rigicon Stainless Steel Dilator 15-16 mm	RSSD-1516	FDA UDI	Class I	Active
Rigicon Dilatom™	9-10 MM	FDA UDI	Class I	Active
Rigi10™	RG1011	FDA UDI	Class II	Unknown
Rigicon HL Dilator 15 – 16 mm	RSUD-1516	FDA UDI	Class I	Active
Rigicon Stainless Steel Dilator 13-14 mm	RSSD-1314	FDA UDI	Class I	Active
Rigicon Furlow Insertion Tool	RSUF-1000	FDA UDI	Class I	Active
Rigi10™	RG1013	FDA UDI	Class II	Unknown
Rigicon Stainless Steel Dilator 10-12 mm	RSSD-1012	FDA UDI	Class I	Active
Rigi10™	RG1010	FDA UDI	Class II	Unknown
Rigicon Stainless Steel Dilator 09-10 mm	RSSD-0910	FDA UDI	Class I	Active
Rigi10™	RG1012	FDA UDI	Class II	Unknown
Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm	RSSL-1012	FDA UDI	Class I	Active
Rigicon HL-LEVINE Combo Prosthesis Tool - 10/14 mm	RSSL-1014	FDA UDI	Class I	Active
Rigi10™	RG1009	FDA UDI	Class II	Unknown
Rigicon Stainless Steel Dilator 11-12 mm	RSSD-1112	FDA UDI	Class I	Active
Rigicon Dilatom™	13-14 MM	FDA UDI	Class I	Active
Rigi10 Malleable Penile Prosthesis	K181673	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Rigicon	RSUD-1314	EUDAMEDFDA UDI	Class I	Active
Rigicon	RSUD-1012	EUDAMEDFDA UDI	Class I	Active
Rigicon	RSRK-1000	EUDAMEDFDA UDI	Class I	Active
Rigicon	RSUD-1112	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Rigicon B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

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

Rigicon As Bakirkoy Istanbul · TR FEI 3013960851