Sewa Medicals Ltd · 89-08 · INDIA
For Sewa Medicals Ltd, import alert is 89-08; country is INDIA; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html