Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsCleaning, disinfection and sterilisation instruments
Plasma sterilisers
EMDN code Z12011309
Manufacturers registered in Europe (EUDAMED) 11
- 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) 18
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 |
|---|---|---|---|
| Zimmer, Inc. Present in Europe in other categories | United States | Trilogy® NexGen® Gender Solutions® Natural-Knee® Prolong® | registered |
| Ideate Medical | United States | SteroScope Biopsy Connector Assembly, Type R1, Qty 1 SteroScope Sterilization Container SteroScope Olympus Vent Connector Assembly, Qty 1 SteroScope Pipette Connector Assembly, Type 3, Qty 1 SteroScope Insert Connector Extra Small, Type R1, Qty 1 SteroScope Insert Connector Small Assembly Type 2, Qty 1 | K233762 (2024) |
| Steris Mexico, S. de R.L. de C.V. | – | V-PRO | registered |
| Plasmapp Co,., Ltd. | South Korea | STERILINK™ | K231169 (2023) |
| Welch Allyn, Inc. Present in Europe in other categories | United States | Welch Allyn, Inc. | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| Dreamtech co., ltd. | South Korea | – | registered |
| ETHICON, Inc. | United States | – | registered |
| Imperial Trading Limited | Barbados | – | registered |
| Innopex Limited | Canada | – | registered |
| Jabil Inc. | United States | – | registered |
| Lowtem Co., Ltd. | South Korea | – | K231893 (2024) |
| Ningbo Incote Precision Machinery Co., Ltd. | China | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Sterilucent, Inc. | United States | – | K190005 (2019) |
| Zimmer Biomet APAC DFE | China | – | registered |
| ZimmerBiomet Americas DFE | United States | – | registered |
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