Manufacturer registered with FDA

Ribbel International Limited

NEW DELHI, DELHI, India. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9039217Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
14151 registrations outside the US
Establishments
1India

Registered in 14 markets

Where regulators' registries name Ribbel International Limited as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedIndia: 96 registrationsBrazil: 17 registrationsColombia: 8 registrationsIsrael: 7 registrationsSouth Korea: 6 registrationsAustralia: 5 registrationsTaiwan: 3 registrationsEgypt: 2 registrationsSaudi Arabia: 2 registrationsSerbia: 2 registrationsHong Kong: 1 registrationsPeru: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: IndiaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerRibbel International Limited1 device types—Below
IndiaCDSCORegistration holderRibbel International962020–2026Pure Global AI
BrazilANVISAManufacturerRIBBEL INTERNATIONAL LTD.RIBBEL INTERNATIONAL LIMITED172011–2026Pure Global AI
ColombiaINVIMAManufacturerRIBBEL INTERNATIONAL LIMITEDRIBBEL INTERNATIONAL LTD.8—Pure Global AI
IsraelAMARManufacturerRibbel International LimitedRIBBEL INTERNATIONAL LTD. · RIBBEL International Ltd.7—Pure Global AI
South KoreaMFDSManufacturerRibbel International LimitedRIBBEL INTERNATIONAL LIMITED61999–2020Pure Global AI
AustraliaTGAManufacturerRibbel International Limited52010–2021Pure Global AI
TaiwanTFDAManufacturerRIBBEL INTERNATIONAL LIMITEDRIBBEL INTERNATIONAL LTD.32005–2011Pure Global AI
EgyptEDAManufacturerRIBBEL INTERNATIONAL LIMITED,22023–2024Pure Global AI
Saudi ArabiaSFDAManufacturerRIBBEL INTERNATIONAL LTD2—Pure Global AI
SerbiaALIMSManufacturerRibbel International Ltd.22024–2024Pure Global AI
Hong KongMDDManufacturerRibbel International Ltd.12026–2026Pure Global AI
PeruDIGEMIDManufacturerRIBBEL INTERNATIONAL LTD.12018–2018Pure Global AI
United KingdomMHRAManufacturerRibbel International Ltd1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Ribbel International Limited currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Biopsy PunchEME · Class 1Dental hand instrumentsMaker
RIBBEL
2010

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
RIBBEL INTERNATIONAL LTD.FDA reg. 9680890SONEPAT Haryana, IndiaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9039217). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.