Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsEndoscopic capsules instruments
Endoscopic capsules
EMDN code Z12021201
Manufacturers registered in Europe (EUDAMED) 1
- 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 |
|---|---|---|---|---|
| IntroMedic FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | South Korea | IIa 93/42 | Website 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) 12
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 |
|---|---|---|---|
| Given Imaging , Ltd. | Israel | PillCam RAPID PillCam Genius | K170210 (2017) |
| Olympus Medical Systems Corp. Present in Europe in other categories | Japan | BATTERY PACK ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE ENDOCAPSULE SOFTWARE 10 LIGHT ENDOCAPSULE SOFTWARE 10 LEAD ANTENNA UNIT CAPSULE ACTIVATOR | K183053 (2019) |
| ANX ROBOTICA CORP | United States | NaviCam SB Capsule NaviCam XS Capsule/Tether NaviCam XS Capsule NaviCam ESView 3.X NaviCam SB Capsule/Tether NaviCam Data Recorder | K233229 (2024) |
| CapsoVision, Inc. Present in Europe in other categories | United States | CapsoRetrieve CapsoCam Plus CE Deliver CapsoView CapsoCloud CapsoAccess | K252480 (2025) |
| Ankon Technologies Co., Ltd. Present in Europe in other categories | China | NaviCam Small Bowel Capsule Endoscopy System | K221590 (2022) |
| US Endoscopy | United States | AdvanCE | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| Given Imaging Ltd. (D.B.A. Medtronic) | Israel | – | K240276 (2024) |
| Given Imaging Ltd. (Medtronic) Present in Europe in other categories | Israel | – | K230991 (2023) |
| Olympus America, Inc. Present in Europe in other categories | United States | – | registered |
| STERIS Corporation Present in Europe in other categories | United States | – | registered |
| United States Endoscopy Group, Inc. Present in Europe in other categories | United States | – | K163495 (2017) |
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