Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsGenitourinary endoscopy instruments
Hysteroscopes
EMDN code Z12020704
Manufacturers registered in Europe (EUDAMED) 28
- 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.
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) 75
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 |
|---|---|---|---|
| STRYKER CORPORATION Present in Europe in other categories | United States | SPY Ideal Eyes | registered |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | USA Elite Elite 2 System USA Elite System USA Series Gyrus ACMI SlimLine | K092278 (2009) |
| NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | United States | AED AED Hystero Pointed Scissor, Single Action AED Hystero Sheath Double Seal Leur Cap Rat Tooth Grasper, D/A, Rotating, 3mm x 37cm Cup Biopsy, Double Action Tenaculum, Double Action | K141515 (2015) |
| SOPRO-COMEG GmbH | Germany | Hysteroscopy sheath Hysteroscope Hysteroscopy obturator Accessory for gynecology Cystoscopy instrument Grasping forceps | registered |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | TRUCLEARTM Control Unit TRUCLEARTM TRUCLEARTM Operative Hysteroscope 8.0 TRUCLEARTM Handpiece TRUCLEARTM Operative Hysteroscope 5.0 TRUCLEARTM Obturator | K161763 (2016) |
| Minerva Surgical, Inc. | United States | HERizon Medical Endoscope Image Processor Resectr Resection Device 9FR (3.0 mm) Resectr Resection Device 5FR (1.65 mm) HERizon Vista Single Use Hysteroscope, Pro Symphion 6.3 Hysteroscope INFINITY Fluid Management Accessory | registered |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| Lina Medical Aps Present in Europe in other categories | Denmark | LiNA OperåScope™ Needle 8mm LiNA OperåScope™ Recording Module LiNA OperåScope™ with HDMI cable & LCD LiNA OperaScope™ with HDMI cable LiNA OperåScope™ Needle 4mm | K193007 (2020) |
| Uvision360, Inc. | United States | LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMINELLE DTx 360 Rotatable Disposable Sheaths Uvision Hysteroscope Cable LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic) Luminelle DTx Control Hub LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath | K192278 (2019) |
| Coopersurgical, Inc. Present in Europe in other categories | United States | Endosee Endosee Advance Cannula with Pipet Endosee System Endosee® Dx Cannula | K200038 (2020) |
| MEDIVISION, INC. | United States | MEDIVISION | registered |
| Caldera Medical, Inc. | United States | Benesta Hysteroscope Set Benesta Single-Use Seals Benesta Fluid Pack Benesta Hysteroscope Adapter Benesta Tissue Removal Device | K233500 (2023) |
| STRYKER SUSTAINABILITY SOLUTIONS, INC. | United States | – | K201756 (2020) |
| COGENTIX MEDICAL, INC. Present in Europe in other categories | United States | EndoSheath Technology Flexible Fiberoptic Cystoscope Flexible Fiberoptic Cystoscope - Intuitive | registered |
| Olympus Medical Systems Corp. Present in Europe in other categories | Japan | OES HYSTEROFIBERSCOPE VISERA HYSTEROVIDEOSCOPE | K221557 (2022) |
| AMERICAN MEDICAL ENDOSCOPY, INC. | United States | Strauss Surgical | K253020 (2026) |
| OBP CORPORATION | – | SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO | registered |
| Polygon Medical, Inc. | United States | Polygon | K182675 (2019) |
| AD Supply Group Limited | United Kingdom | – | registered |
| APICAL INSTRUMENTS | United States | – | registered |
| ATC Technologiess Inc. | United States | – | registered |
| ATL Technology LLC | United States | – | registered |
| Acuvu, Inc. | United States | – | K211227 (2021) |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Axora Medical, Inc. | United States | – | K260984 (2026) |
| BURAK GLOBAL IC VE DIS TIC LTD STI | Türkiye | – | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | – | K191538 (2020) |
| Boyd Weiler GmbH & Co. KG | Germany | – | registered |
| Bruetsch Technology AG | Switzerland | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| Conmed Corporation Present in Europe in other categories | United States | – | registered |
| Corinth Medtech, Inc. | United States | – | K191335 (2019) |
| Hangzhou Fushan Medical Appliance Co., Ltd. | China | – | registered |
| Hysterovue, Inc. | United States | – | K202445 (2021) |
| IVUS ILAC SANAYI VE TICARET AS | Türkiye | – | registered |
| Ian Jamieson Pty Ltd | Australia | – | registered |
| Jabil Inc. | United States | – | registered |
| KARL STORZ Endoscopy-America, Inc. | United States | – | K223885 (2023) |
| KOSCHER & WUERTZ GMBH | Germany | – | registered |
| Lake Region Medical | United States | – | registered |
| MDTGlobal, a.s. | Slovakia | – | registered |
| MEDRES Medical Engineering Ltd. | Hungary | – | registered |
| MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI | Türkiye | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| NAS MED LLC FZ | United Arab Emirates | – | registered |
| Ningbo Skonsion Electronics Ltd. | China | – | registered |
| Nissha Medical Technologies Present in Europe in other categories | United States | – | registered |
| Nvision Medical | United States | – | K160510 (2016) |
| OPCOM INC. | Taiwan | – | registered |
| Obp Medical | United States | – | K091838 (2009) |
| Olympus America, Inc. Present in Europe in other categories | United States | – | K954488 (1997) |
| Origyn Medical Technology (Hangzhou) Co., Ltd. | China | – | K240401 (2024) |
| PAJUNK GmbH Medizintechnologie | Germany | – | registered |
| Peter's Technology (Suzhou) Co., Ltd. | China | – | registered |
| Primo Medical Group, Inc | United States | – | registered |
| Process Control Services | United States | – | registered |
| Qingdao O-Mec Medical Technology Co., Ltd. | China | – | registered |
| RZ-Medizintechnik GmbH Present in Europe in other categories | Germany | – | K243382 (2025) |
| Reed Medical (Zhejiang) Co., Ltd. | China | – | K190797 (2019) |
| Robling Medical, LLC | United States | – | registered |
| SEISA MEDICAL INC. d.b.a Tekni-Plex Healthcare | United States | – | registered |
| SENTINEL CH. SPA Present in Europe in other categories | Italy | – | registered |
| STERIPAC GMBH | Germany | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Schoelly Fiberoptic GmbH | Germany | – | K201970 (2020) |
| Shanghai AnQing Medical Instrument Co., Ltd. Present in Europe in other categories | China | – | K254251 (2026) |
| Strub Medical GmbH & Co. KG Present in Europe in other categories | Germany | – | registered |
| Stryker Endoscopy Present in Europe in other categories | United States | – | K252012 (2025) |
| TONTARRA MEDIZINTECHNIK GMBH Present in Europe in other categories | Germany | – | registered |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | – | registered |
| Uroviu Corporation Present in Europe in other categories | United States | – | registered |
| Viant Medical, LLC | United States | – | registered |
| Vomed Volzer Medizintechnik GmbH & Co. | Netherlands | – | registered |
| asap GmbH | Germany | – | registered |
| jr-medizintechnik GmbH & Co KG | Germany | – | registered |
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