Manufacturer registered with FDA

PAJUNK GmbH Medizintechnologie

Geisingen, Germany. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator8010639Manufacturer
Device types listed
1
Brands and models
4
510(k) clearances
0as applicant
Markets registered in
16604 registrations outside the US
Establishments
1Germany

Registered in 16 markets

Where regulators' registries name PAJUNK GmbH Medizintechnologie as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedCanada: 273 registrationsSaudi Arabia: 117 registrationsUnited Kingdom: 61 registrationsSouth Korea: 34 registrationsAustralia: 24 registrationsBrazil: 17 registrationsTaiwan: 16 registrationsIsrael: 12 registrationsPeru: 12 registrationsChina: 11 registrationsColombia: 8 registrationsSerbia: 8 registrationsHong Kong: 6 registrationsCosta Rica: 4 registrationsEgypt: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerPAJUNK GmbH Medizintechnologie1 device types—Below
CanadaHealth CanadaRegistration holderPAJUNK GMBH MEDIZINTECHNOLOGIE2731999–2026Pure Global AI
Saudi ArabiaSFDAManufacturerPajunk GmbH MedizintechnologiePAJUNK GmbH Medizintechnologie117—Pure Global AI
United KingdomMHRAManufacturerPAJUNK GmbH Medizintechnologie61—Pure Global AI
South KoreaMFDSManufacturerPajunk GmbH MedizintechnologiePAJUNK GMBH Medizintechnologie · PAJUNK GmbH Medizintechnologie342004–2026Pure Global AI
AustraliaTGAManufacturerPajunk GmbH Medizintechnologie242006–2026Pure Global AI
BrazilANVISAManufacturerPAJUNK GMBH MEDIZINTECHNOLOGIE172016–2024Pure Global AI
TaiwanTFDAManufacturerPAJUNK GMBH MEDIZINTECHNOLOGIE162006–2019Pure Global AI
IsraelAMARManufacturerPajunk GmbH MedizintechnologiePAJUNK GMBH Medizintechnologie12—Pure Global AI
PeruDIGEMIDManufacturerPAJUNK GmbH MEDIZINTECHNOLOGIE122018–2026Pure Global AI
ChinaNMPARegistration holder德国宝雅医疗科技有限公司PAJUNK GmbH Medizintechnologie德国宝雅医疗科技有限公司Pajunk GmbH Medizintechnologie11—Pure Global AI
ColombiaINVIMAManufacturerPAJUNK GMBH MEDIZINTECHNOLOGIE8—Pure Global AI
SerbiaALIMSManufacturerPajunk GmbH Medizintechnologie82025–2026Pure Global AI
Hong KongMDDManufacturerPAJUNK GmbH MedizintechnologiePajunk GmbH Medizintechnologie62016–2026Pure Global AI
Costa RicaMinisterio de SaludManufacturerPAJUNK GmbH Medizintechnologie4—Pure Global AI
EgyptEDAManufacturerPAJUNK® GmbH Medizintechnologie,12024–2024Pure 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 PAJUNK GmbH Medizintechnologie currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Irrigating Endodontic Periodontic SyringeEIC · Class 1Dental hand instrumentsMaker
PLURAJECTUNIJECTVARIOJECTVARIOSAFE
2007

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
PAJUNK GMBH MEDIZINTECHNOLOGIEFDA reg. 9611612GEISINGEN Baden-Wurttemberg, GermanyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010639). 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.