IVD instrumentsHematology / histology / cytology instrumentsHistology / cytology
Cervical screening systems
EMDN code W02020502
Manufacturers registered in Europe (EUDAMED) 8
- 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 |
|---|---|---|---|---|
| CooperSurgical FDA EU representative : CooperSurgical Distribution B.V. (Netherlands) | United States |
|
I MDR | RA-CSI@coopersurgical.com EUDAMED record Report an error |
| Datexim | France |
|
– 98/79 | Website contact@datexim.com EUDAMED record Report an error |
| Hologic FDA EU representative : Hologic BV (Belgium) | United States | C IVDR | EUDAMED record Report an error | |
| Newmars Technologies Kft | Hungary |
|
IIa 93/42 | EUDAMED record Report an error |
| Noul FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | – 98/79 | Website cs@noul.com EUDAMED record Report an error | |
| Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands) | China | – 98/79 | Website service@reetoo.com.cn EUDAMED record Report an error | |
| Shandon Diagnostics FDA EU representative : Epredia Netherlands B.V. (Netherlands) | United Kingdom (ex Northern Ireland) | A IVDR | EUDAMED record Report an error | |
| YD Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | Website admin@yd-diagnostics.com 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) 22
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 |
|---|---|---|---|
| Andwin Scientific | United States | Andwin Scientific Papette Andwin Rovers Safetex | K983599 (1998) |
| Rovers Medical Devices B.V. | United States | Rovers® Cervex-Brush® Rovers® Cervex-Brush® Combi Rovers® EndoCervex-Brush® Rovers® Viba-Brush® Rovers® Cervex-Brush® RT Rovers® EndoCervex-Brush®-S RT | K043369 (2005) |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| Medical Packaging Corp. | United States | CytoSoft CYTO-PAK | K870398 (1987) |
| AERO-MED, LLC | – | Aero-Med | registered |
| NORTH EOS INDUSTRIES INC. Present in Europe in other categories | Taiwan | EOS | K963685 (1996) |
| Puritan Medical Products | United States | Puritan Histobrush® Puritan Histobrush Puritan Histobrush Cytology Brush | K111681 (2012) |
| Team Technologies, Inc. | United States | Cytology Brush 6.5" Cytology Brush | K971849 (1997) |
| Kolplast C I | Brazil | KOLPLAST | K153128 (2017) |
| QIAGEN SCIENCES INC. Present in Europe in other categories | United States | digene® HC2 DNA Collection Device | registered |
| RECE INTERNATIONAL CORPORATION | – | ViaMed | registered |
| SKLAR CORPORATION | – | Sklar® | registered |
| Advanced Engineering, Inc. | United States | – | registered |
| Cancer Diagnostics, Inc. | United States | – | registered |
| Cordica Medical (Formally Team Technologies, Inc) | United States | – | registered |
| Excell Company, LLC | United States | – | K182049 (2019) |
| Hardwood Products Co., LP | United States | – | K961934 (1996) |
| JIANGSU SUYUN MEDICAL MATERIALS CO., LTD. | China | – | registered |
| Kolplast CI Ltda Present in Europe in other categories | Brazil | – | registered |
| MedGyn Products, Inc. | United States | – | registered |
| SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. | China | – | registered |
| THE ANDWIN CORP. | United States | – | registered |
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