Instruments for functional explorations and therapeutic interventionsENT instruments
ENT treatment units
EMDN code Z121402
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) 13
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 |
|---|---|---|---|
| Jedmed Instrument Co. | United States | JEDMED | K953457 (1995) |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| Medical Technology Industries, Inc. | United States | MTI | registered |
| SONTEC INSTRUMENTS, INC. | United States | EN100 TL HANDLE EXTRA CORD EN50 BASE UNIT MPACK MINATURE BELT CLIP LED PLUG IN TRANSFORMER MPACK | registered |
| Haag-Streit AG Present in Europe in other categories | Switzerland | Reliance | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| Aesculap, Inc. Present in Europe in other categories | United States | – | registered |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. Present in Europe in other categories | China | – | registered |
| Boyd Industries, Inc. | United States | – | registered |
| ENDONEST MEDICAL SYSTEMS LLP | India | – | registered |
| M.I.One Co.,Ltd. Present in Europe in other categories | South Korea | – | registered |
| PREMIER DENTAL PRODUCTS COMPANY | United States | – | K945395 (1995) |
| PROFESSIONAL SPECIALTIES CO., INC. | United States | – | registered |
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