Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instruments
Upper gastrointestinal tract endoscopy instruments
EMDN code Z120205
Manufacturers registered in Europe (EUDAMED) 35
- 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) 14
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 |
|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | China | Single-use Video Scope eyeMAX(TM) PB Digital Controller | K221784 (2023) |
| Richard Wolf GmbH Present in Europe in other categories | Germany | RIWO | registered |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | Gyrus ACMI | registered |
| HOYA CORPORATION | United States | PENTAX | registered |
| CENTERPOINT SYSTEMS LLC | United States | Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps | K233752 (2024) |
| Pentax of America, Inc. Present in Europe in other categories | United States | FIBER PANCREATOSCOPE | registered |
| Tangent Endoscopy, LLC | United States | Tangent Digital catheter | K251170 (2025) |
| Cordica Medical (Formally Team Technologies, Inc) | United States | – | registered |
| ENERCON TECHNOLOGIES | United States | – | registered |
| Endocure Technologies, Inc. | United States | – | K161147 (2016) |
| HOYA Corporation PENTAX Division | United States | – | registered |
| Ian Jamieson Pty Ltd | Australia | – | registered |
| Mirco-Tech (Nanjing) Co., Ltd. | China | – | K254153 (2026) |
| Ningbo Wise Optomech Technology Corporation Present in Europe in other categories | China | – | registered |
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