Manufacturer registered with FDA
Aesculap Chifa SP. Z O.O.
NOWY TOMYSL, Poland. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8312 registrations outside the US
- Establishments
- 1Poland
Registered in 8 markets
Where regulators' registries name Aesculap Chifa SP. Z O.O. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Aesculap Chifa SP. Z O.O. | 9 device types | — | Below |
| South Korea | MFDS | Manufacturer | AESCULAP CHIFA Sp. z o. o.AESCULAP - Chifa Sp. z o.o. · Aesculap CHIFA Sp.zo.o · +2 | 276 | 2002–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | AESCULAP CHIFA SP. Z O. O.AESCULAP CHIFA SP.Z.O.O. · AESCULAP CHIFA SP. Z O.O. · +2 | 17 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | AESCULAP CHIFA SP. Z O.O.Aesculap Chifa Sp. ZO.O. | 10 | 1998–2016 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Aesculap Chifa Sp. z o.o. | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AESCULAP CHIFA SP.ZO.O. | 2 | 2005–2006 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | AESCULAP CHIFA SP. Z O.O.Aesculap Chifa SP. Z O.O. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | AESCULAP CHIFA Sp. zo. o. | 1 | 2013–2013 | 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 Aesculap Chifa SP. Z O.O. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | BAND HOLDERSFURRER PLIERSHOW LIGATURE PLIERS | 2006 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | SCISSORS, SURGICAL TISSUE, DENTALVARIOUS TYPES AND SIZES OF SCISSORS | 2006 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | CROWN SCISSORSSCISSORS, COLLAR AND CROWN | 2006 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | AIMSWORTHBREWERFORCEPS, RUBBER DAM CLAMP | 2006 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | MAGNUM MEDICAL INC. | 2013 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | FORCEPS, TOOTH EXTRACTOR, SURGICALVARIOUS TYPES OF ENGLIS | 2006 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | FORCEPS, RONGEUR, SURGICAL | 1998 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | DENTAL ELEVATORSELEVATOR, SURGICAL, DENTALVARIOUS MODELS SURGICAL | 2006 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | PLIER, ORTHODONTIC | 1993 |
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
| Establishment | Location | What it does |
|---|---|---|
| AESCULAP CHIFA SP. Z O.O.FDA reg. 9680260 | NOWY TOMYSL Wielkopolskie, Poland | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007699). 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.