Sewa Medicals Ltd · 89-08 · INDIA
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
- 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
- Address
- Gut No. 229-232, Alandi Markal Road , Village Markal Taluka Khed, Taluka:Khed , Pune, Maharashtra INDIA verified
- Date published
- 06/06/2014 verified
- Product code
- 80 F - - MF Syringe, Piston | 80 K - - ZH Introducer, Syringe Needle | 80 M - - EG Syringe, Antistick each item verified
- Product
- Medical Syringes | Medical Syringes | Medical Syringes each item verified
- FDA notes
- class II | class II | class II each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.