Manufacturer registered with FDA
Cooper Surgical Inc
Trumbull, CT, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 171,381 registrations outside the US
- Establishments
- 1United States
Registered in 17 markets
Where regulators' registries name Cooper Surgical Inc 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 | Cooper Surgical Inc | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | COOPERSURGICAL, INC. | 417 | 1999–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Cooper Surgical, Inc.CooperSurgical Inc. · CooperSurgical, Inc. · +1 | 182 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | CooperSurgical, Inc. | 145 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | CooperSurgical, Inc. | 108 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | CooperSurgical, Inc.COOPER SURGICAL INC · COOPERSURGICAL INC · +1 | 95 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | COOPERSURGICAL, INC.COOPERSURGICAL INC. · COOPER SURGICAL, INC. | 75 | 2002–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | CooperSurgical IncCooper Surgical Inc | 73 | 2008–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | COOPERSURGICAL INCCOOPERSURGICAL, INC. · COOPER SURGICAL · +1 | 69 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | CooperSurgical, Inc.Coopersurgical Inc · CooperSurgical Inc. · +2 | 44 | 1999–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | CooperSurgical, Inc.Cooper Surgical Inc. · CooperSurgical Inc. · +2 | 41 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | COOPERSURGICAL, INC.COOPER SURGICAL INC. · CooperSurgical, Inc. · +2 | 40 | 1992–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | COOPERSURGICAL INC.COOPER SURGICAL INC · COOPERSURGICAL, INC. · +1 | 32 | 2018–2026 | Pure Global AI |
| China | NMPA | Registration holder | 库柏外科手术公司CooperSurgical, Inc.库柏外科手术公司 CooperSurgical, Inc. · 库柏外科手术公司CooperSurgical,Inc. · +1 | 30 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | CooperSurgical, Inc. | 24 | 2024–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | CooperSurgical, Inc.CooperSurgical, Inc | 5 | 2025–2026 | Pure Global AI |
| Egypt | EDA | Manufacturer | COOPERSURGICAL INC,, | 1 | 2023–2023 | 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 Cooper Surgical Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | DISPOSA-DERMEuro-Med Skin Punch[Skin Punch] | 1994 |
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 |
|---|---|---|
| COOPERSURGICAL, INC.FDA reg. 1216677 | Trumbull, CT, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9002384). 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.