COOPERSURGICAL, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 6 510(k) filings: 0 Recalls: 2

Known Identifiers & Locations

FEI Numbers 1216677, 1627186, 3002807462, 3002895220, 3014295858, 3014755376
Owner Operator Numbers 9002384
Locations Covered BERLIN, DE; Herten Limburg, NL; La Garita Alajuela, CR; Stafford, TX, US; TUTTLINGEN Baden-Wurttemberg, DE; Trumbull, CT, US

Registered Establishments (6)

Registration # Establishment Name Location Establishment Type(s) Action
1216677 COOPERSURGICAL, INC. Trumbull, CT, US Manufacture Medical Device View Details
1627186 Lone Star Medical Products Stafford, TX, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3014295858 COOPER MEDICAL, SRL La Garita Alajuela, CR Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3014755376 CooperSurgical Distribution B.V. Herten Limburg, NL Export Device to the United States But Perform No Other Operation on Device View Details
8010251 HBH MEDIZINTECHNIK GMBH TUTTLINGEN Baden-Wurttemberg, DE Manufacture Medical Device View Details
9611604 LEISEGANG FEINMECHANIK-OPTIK GMBH BERLIN, DE Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (2)

Recall # Product Description Initiation Date Status Action
Z-0005-05 Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047 Reason: Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System 2004-08-17 Terminated View Details
Z-0029-2020 Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure. Reason: The touchpad may not work properly after cleaning. 2019-09-05 Terminated View Details

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