Unit, Drying
Clinical Chemistry · 21 CFR 862.2050
Recent MDR events
4 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Cenorin, LLCTerminatedUnknown
ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
Z-3032-2017 · View FDA record ↗ - Cenorin, LLCTerminatedUnknown
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
Z-3033-2017 · View FDA record ↗ - Cenorin, LLCTerminatedUnknown
ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
Z-3034-2017 · View FDA record ↗
Registered firms
24 firms currently registered for this product code
International Manufacturing Solutions Operaciones
Cd. Juarez Chihuahua, MX
Scitek Global Co.,ltd
Jinan Shandong, CN
Labotek Group Corp
Bayamon, PR, US
Sheldon Mfg., Inc.
CORNELIUS, OR, US
Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.s.
ANKARA, TR
Globe Scientific, Llc
Mahwah, NJ, US
Ningbo Greetmed Medical Instruments Co., Ltd.
Ningbo Zhejiang, CN
Cenorin, Llc
KENT, WA, US
Infitek Co., Ltd.
Shanghai, CN
Capsa Healthcare
Canal Winchester, OH, US
Mg Developpement
mauguio Herault, FR
Madison Polymeric Engineering
BRANFORD, CT, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Wassenburg Medical, Inc.
Ivyland, PA, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Medihub Co., Ltd.
Gunpo-si Gyeonggi, KR
Diatrust Medical Co., Ltd.
Nanjing City Jiangsu, CN
Labpeak Co.,ltd
Jinan Shandong, CN
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Steris Canada Ulc
QUEBEC, CA
Mg Development America Inc.
Pittsburgh, PA, US
Steelco S.p.a.
Riese Pio X Treviso, IT
Wassenburg Medical B.v.
Dodewaard Gelderland, NL
Pentax Of America, Inc.
MONTVALE, NJ, US
510(k) clearances
1 clearances for this product code