Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsInstruments for ultrasonic surgery
Instruments for ultrasonic surgery - hardware accessories
EMDN code Z12010880
Manufacturers registered in Europe (EUDAMED) 22
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Shanghai Saints Sages Surgical FDA EU representative : Emergo Europe B.V. (Netherlands) | China |
1 other |
I, IIb MDR | Website EUDAMED record Report an error |
| Olympus FDA EU representative : Olympus Europa SE & Co. KG (Germany) | Japan | I, IIb MDR, 93/42 | EUDAMED record Report an error | |
| Reachsurgical FDA EU representative : MDSS GmbH (Germany) | China | IIb MDR, 93/42 | EUDAMED record Report an error | |
| Innolcon EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
IIb MDR | EUDAMED record Report an error |
| Gyrus ACMI FDA EU representative : Olympus Europa SE & Co. KG (Germany) | United States | I MDR | EUDAMED record Report an error | |
| Hironic FDA EU representative : Obelis s.a. (Belgium) | South Korea |
|
IIb 93/42 | Website ra@hironic.com EUDAMED record Report an error |
| Orthofix FDA | Italy | I, IIa MDR | Website EUDAMED record Report an error | |
| Stryker FDA EU representative : Stryker European Operations Limited (Ireland) | United States | I MDR | Website EUDAMED record Report an error | |
| Surgnova FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
I, IIa MDR | qara@surgnova.com EUDAMED record Report an error |
| Tianjin Huahong Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR | Website EUDAMED record Report an error | |
| Arjo FDA | Sweden |
|
I MDR | Website info@arjo.com EUDAMED record Report an error |
| B.J.ZH.F.Panther Medical Equipment FDA EU representative : Obelis s.a. (Belgium) | China | IIb MDR | Website ra@pantherhealthcare.com EUDAMED record Report an error | |
| Covidien FDA EU representative : Medtronic B.V. (Netherlands) | United States |
|
IIb MDR | EUDAMED record Report an error |
| Ethicon Endo-Surgery FDA EU representative : Johnson & Johnson Medical GmbH (Germany) | United States | I MDR | eudamed_enquiries@its.jnj.com EUDAMED record Report an error | |
| Integralife FDA | Ireland |
|
IIb, III MDR | EUDAMED record Report an error |
| LHbiomed FDA EU representative : TECHNOLUX Srl (Italy) | South Korea |
|
IIb 93/42 | Website EUDAMED record Report an error |
| Mectron FDA | Italy | IIa MDR | Website EUDAMED record Report an error | |
| Solta FDA EU representative : MDSS GmbH (Germany) | United States | I MDR | EUDAMED record Report an error | |
| Sonicmed FDA EU representative : Llins Service & Consulting GmbH (Germany) | China |
|
IIa MDR | EUDAMED record Report an error |
| SRA Developments FDA EU representative : BOWA-electronic GmbH (Germany) | United Kingdom (ex Northern Ireland) |
|
IIb 93/42 | Website EUDAMED record Report an error |
| Tenex Health FDA EU representative : Donawa Lifescience Consulting Srl (Italy) | United States | IIa 93/42 | Website info@tenexhealth.com EUDAMED record Report an error | |
| Wuxi Beien Surgery Device FDA EU representative : Prolinx GmbH (Germany) | China | IIb MDR | Service@Beien-Surgery.com EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 37
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Orthosonics, Ltd. | United Kingdom | OSCAR | K093805 (2010) |
| Satelec | United States | ACTEON SATELEC | K100410 (2010) |
| RADLEY SCIENTIFIC LIMITED Present in Europe in other categories | United Kingdom | TORS | registered |
| W & H Dentalwerk Bürmoos GmbH Present in Europe in other categories | Austria | Piezomed Pro Accessory Piezomed Pro M-PH350 Piezomed Pro M-PM100 | registered |
| Peter Brasseler Holdings, LLC | United States | Axiom Blades Axiom Accessories Axiom Handle Axiom Kit Axiom Generator | registered |
| SMTP Medical Co., Ltd. | China | SMTP | registered |
| Biomet Orthopedics, LLC Present in Europe in other categories | United States | Ultra-Drive® Tool ULTRA-DRIVE TOOL ULTRA-DRIVE® ULTRA DRIVE III HANDPIECE ULTRA DRIVE III CONSOLE ULTRA DRIVE IRRIGATION | registered |
| Karl Storz GmbH & Co. KG Present in Europe in other categories | Germany | n.a. CALCUSON | registered |
| E.M.S Electro Medical Systems S.A Present in Europe in other categories | United States | LITHOCLAST | K230893 (2023) |
| Cybersonics, Inc. | United States | – | K171024 (2017) |
| Electro Medical Systems SA | United States | – | registered |
| Foreasytech S.r.l. | Italy | – | registered |
| Frueh Verpackungstechnik AG | Switzerland | – | registered |
| Intl. Medical Technologies, Inc. | United States | – | registered |
| MAVERA TIBBI CIHAZLAR ANONIM SIRKETI | Türkiye | – | registered |
| MDTGlobal, a.s. | Slovakia | – | registered |
| MIING WEI CO., LTD. | Taiwan | – | registered |
| Misonix, Inc. | United States | – | registered |
| Morley Research Consortium | United States | – | K172464 (2018) |
| Nissha Medical Technologies Present in Europe in other categories | United States | – | registered |
| Primo Medical Group, Inc | United States | – | registered |
| Promepla Present in Europe in other categories | Monaco | – | registered |
| Richard Wolf GmbH Present in Europe in other categories | Germany | – | registered |
| SIMAGEC | France | – | registered |
| Satalec-Acteon Group | France | – | K163610 (2017) |
| Satelec - Acteon Group | United States | – | registered |
| Shenzhen Codyson Electrical Co, Ltd Present in Europe in other categories | China | – | registered |
| Shenzhen Perfect Idea Technology Limited | China | – | registered |
| Single Source Medical LLC | United States | – | registered |
| Smtp Technology Co., Ltd. | China | – | K201274 (2021) |
| Summit Medical , Ltd. Present in Europe in other categories | United Kingdom | – | registered |
| TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD | China | – | registered |
| W&H Dentalwerk Buermoos GmbH | Austria | – | registered |
| W&H Impex Inc. | Canada | – | registered |
| Zimmer Biomet APAC DFE | China | – | registered |
| Zimmer, Inc. Present in Europe in other categories | United States | – | registered |
| ZimmerBiomet Americas DFE | United States | – | registered |
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