# Arck Technologies Innovations Pvt Ltd (manufacturer, Vasai Maharashtra, IN): 4 new FDA device listings, incl. labware, assisted reproduction, exempt

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Arck Technologies Innovations Pvt Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Vasai Maharashtra, IN |
| New listings | 4 |
| Devices | Labware, Assisted Reproduction, Exempt; Container, Specimen, Non-Sterile; Container, Specimen, Sterile; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Product codes | PUD, NNI, FMH, LXG |
| Device classes | Class I, Class II |
| Medical specialties | Obstetrics/Gynecology, Pathology, Clinical Chemistry |
| Brand names | Pipette Tips; Culture/ Petri Dish- 90mm x 20mm; Centre Well Dish- 57mm x 16mm; Conical 4- well Dish (Vitrification and Cooling Dish); Culture/ Petri Dish- 35mm x 10mm; Culture/ Petri Dish- 57mm x 16mm; ICSI Dish- 50mm x 10mm; 4-well Dish |
| First new listing | 2026-05-18 |
| Latest new listing | 2026-05-18 |
| FDA registration number | 3045853418 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.