IVD generic use consumablesSamples collection devicesUrine collection devices
Urine collection, tubes
EMDN code W05010202
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) 57
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 |
|---|---|---|---|
| COPAN ITALIA SPA Present in Europe in other categories | Italy | UTM® UTM-RT BBL™ CultureSwab™ TransPorter® Transystem™ BD Universal Viral Transport | K232565 (2024) |
| Remel Co. Present in Europe in other categories | United States | MicroTest M4RT MicroTest M6 REMEL MicroTest M5 ^CE^Liq Stuarts,Dual Swab 36mmPK/500 Liquid Stuarts,Wire Shaft PK/50 | K965150 (1997) |
| Shenzhen Dakewe Bio-engineering Co., Ltd Present in Europe in other categories | China | BioSci™ BioSci SNT Biotech | K240235 (2024) |
| MEDICAL CHEMICAL CORPORATION | United States | C&S Medium Total-Fix / C&S / Clean O&P Collection Kits Formalin / C&S / Clean Stool Collection Kits O&P Collection Vials C&S/Clean Kits O&P Collection Vials Formalin/C&S Kits Z-PVA / Formalin / C&S / Clean O&P Collection Kits | K150887 (2015) |
| Hangzhou Bioer Technology Co., Ltd. Present in Europe in other categories | China | BIOER Viral Transport Medium | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| Huachenyang (Shenzhen) Technology Co., Ltd | China | iClean | K212856 (2022) |
| Pretium Canada Packaging ULC | Canada | Starswab Multitrans System Starswab II Bacteriology Culture Collection and Transport System | registered |
| Meridian Bioscience, Inc. Present in Europe in other categories | United States | Para-Pak C&S Para-Pak SAF / Clean / C&S Para-Pak Zn-PVA / 10% Formalin / C&S Para-Pak EcoFix / C&S / Clean Meridian Viral Transport | registered |
| Puritan Medical Products | United States | Puritan Puritan® UniTranz-RT® VWR Puritan Fecal OptiSwab | K162284 (2016) |
| Hangzhou Genesis Biodetection & Biocontrol Co., LTD. Present in Europe in other categories | China | KaiBiLi Extended ViralTrans | K231027 (2023) |
| CLARK LABORATORIES, INC. | United States | Bartels | registered |
| Jinan Babio Biotechnology Co., Ltd. | China | Babio | K250205 (2025) |
| Sarstedt Aktiengesellschaft & Co.KG | – | Urine Monovette Boric Acid 8,5 ml Urine Monovette Boric Acid 3,2 ml Urine Monovette® 10ml bor.acid | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Merit Medical Systems, Inc. Present in Europe in other categories | United States | Cultura™ | K201674 (2021) |
| Bioteke Corporation (Wuxi) Co., Ltd. Present in Europe in other categories | China | BioTeke | K211707 (2022) |
| Cepheid Present in Europe in other categories | United States | Xpert Urine Specimen Collection Kit Xpert Nasopharyngeal Sample Collection Kit Xpert® | registered |
| ACESO LABORATORIES INC. Present in Europe in other categories | United States | Atida Viral Transport Medium (Non-inactivated Type) | registered |
| HARDY DIAGNOSTICS | United States | TransPRO | K233534 (2024) |
| A. L. B. LUZ | Brazil | Viral Transport Media (VTM) 3ml | K232454 (2024) |
| Alpha-TEC Systems, Inc. | United States | Alpha-Tec Systems | registered |
| BIO-MED DIAGNOSTICS, INC. Present in Europe in other categories | – | VTM-C19 Transit Tube | registered |
| Hangzhou AllTest Biotech Co., Ltd. Present in Europe in other categories | China | AllTest Viral Transport Medium | K242576 (2025) |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline Industries, Inc. | registered |
| Oxoid U.S.A., Inc. Present in Europe in other categories | United States | CARY-BLAIR MEDIUM | registered |
| Arx Sciences, Inc. | United States | – | K231843 (2024) |
| Azer Scientific, Inc. | United States | – | K202531 (2024) |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CITOTEST LABWARE MANUFACTURING CO., LTD. Present in Europe in other categories | China | – | registered |
| Changsha Renji Medical Equipment Co., Ltd. | China | – | registered |
| Citotest Scientific Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Dylan Lucas International Inc | Canada | – | registered |
| Ensol Biosciences, Inc. | South Korea | – | K220908 (2024) |
| GREINER BIO-ONE NA | United States | – | K163436 (2017) |
| Hanchang Medic Co., Ltd. (Han Chang Medic) | South Korea | – | K233449 (2024) |
| Hangzhou Best Valley Medical Technology Co., Ltd | China | – | registered |
| Hardwood Products Co., LP | United States | – | registered |
| Himedia Laboratories Private Limited | India | – | registered |
| IMMCO DIAGNOSTICS, INC. | United States | – | registered |
| Imperial Trading Limited | Barbados | – | registered |
| Innopex Limited | Canada | – | registered |
| Liofilchem S.R.L. | Italy | – | registered |
| MEDEGEN MEDICAL PRODUCTS, LLC | United States | – | registered |
| MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED | United Kingdom | – | K242976 (2025) |
| MML Diagnostics Packaging | United States | – | registered |
| Maya Medical Top Trade Ltd. | Israel | – | registered |
| Medical Wire & Equipment Co. | United States | – | K872213 (1987) |
| Medschenker, Inc. | United States | – | K212743 (2023) |
| ORTA MEDICAL LTD | Israel | – | registered |
| STS Corporation | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Trinity Biotech USA Present in Europe in other categories | United States | – | registered |
| Vectornate Korea Inc | South Korea | – | registered |
| Wuxi Nest Biotechnology Co., Ltd. Present in Europe in other categories | China | – | K211256 (2022) |
| Xcell Therapeutics Inc. | South Korea | – | registered |
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