# Sewa Medicals Ltd · 89-08 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For Sewa Medicals Ltd · 89-08 · INDIA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is INDIA; product is Medical Syringes | Medical Syringes | Medical Syringes; product code is 80 F - - MF Syringe, Piston | 80 K - - ZH Introducer, Syringe Needle | 80 M - - EG Syringe, Antistick; date published is 06/06/2014; address is Gut No. 229-232, Alandi Markal Road , Village Markal Taluka Khed, Taluka:Khed , Pune, Maharashtra INDIA, verified against its source on 2026-09-16.

- **Firm:** Sewa Medicals Ltd _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** INDIA _(verified: appears in the quote below)_
- **Address:** Gut No. 229-232, Alandi Markal Road , Village Markal Taluka Khed, Taluka:Khed , Pune, Maharashtra INDIA _(verified: appears in the quote below)_
- **Date published:** 06/06/2014 _(verified: appears in the quote below)_
- **Product code:** 80 F - - MF Syringe, Piston | 80 K - - ZH Introducer, Syringe Needle | 80 M - - EG Syringe, Antistick _(verified: each item appears in the quote below)_
- **Product:** Medical Syringes | Medical Syringes | Medical Syringes _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II | class II _(verified: each item appears in the quote below)_

## What the source says

> Sewa Medicals Ltd Date Published : 06/06/2014 Gut No. 229-232, Alandi Markal Road , Village Markal Taluka Khed, Taluka:Khed , Pune, Maharashtra INDIA 80 F - - MF Syringe, Piston Date Published: 06/06/2014 Desc: Medical Syringes Notes: class II 80 K - - ZH Introducer, Syringe Needle Date Published: 06/06/2014 Desc: Medical Syringes Notes: class II 80 M - - EG Syringe, Antistick Date Published: 06/06/2014 Desc: Medical Syringes Notes: class II

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).