Swemed Lab International AB
Country not established
- Devices
- 4
What Swemed Lab International AB makes
Swemed Lab International AB manufactures pipettes and catheter sets designed for assisted reproductive technology procedures, including blastomere biopsy pipettes, follicle aspiration sets, and embryo transfer catheters. Their products also include micro-injection pipettes, holding pipettes, and denuding pipettes for intracytoplasmic sperm injection (ICSI) and other embryo manipulation tasks.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Swemed Lab International AB have in the registry?
The registry currently lists 4 devices for Swemed Lab International AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Swemed Lab International AB's devices?
Among its 4 most recently registered devices, Swemed Lab International AB has devices listed in FDA 510(k) (4 devices).
What risk classes do Swemed Lab International AB's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Swemed Lab International AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Swemed Lab International AB in the registry?
The most recently registered devices listed for Swemed Lab International AB include BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540, SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE, CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET and SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO.