FDA Registration
Active
🇹🇷 Türkiye
Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S.
Reg #: 3017059795
·
FEI: 3017059795
·
Expires 2026
Products
12
Proprietary Names
14
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S.
- Registration Number
- 3017059795
- FEI Number
- 3017059795
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Velimese Osb. Mah. 242 Sok. Subiomedikal Blok No:9/2 Ergene
- City
- Tekirdag
- Country
- TR
Owner / Operator
- Firm Name
- Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A.S.
- Operator Number
- 10074958
- Address
- Velimese Osb. Mah. 242 Sok. Subiomedikal Blok No:9/2 Ergene
- City
- Tekirdag
- State
- TR-59
- Postal Code
- 59930
- Country
- TR
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Emily Matorin
- Address
- 1 Prospect Park West Ste 4D Brooklyn, NY 11215
- City
- Brooklyn
- State
- NY
- ZIP
- 11215
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Start/Stop (Including Contents), Dialysis | FKG | Class 1 | Gastroenterology, Urology | No | 2023-09-13 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2023-03-01 |
| Foley Catheter Kit (Excludes Hiv Testing) | PPB | Class 2 | Gastroenterology, Urology | No | 2026-06-09 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-06-03 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-07-17 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2024-09-30 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2026-06-09 |
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2024-09-30 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2026-06-09 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-09-30 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2026-06-09 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-09-11 |
Proprietary Names
Dialysis Set, Catheter Set
EASY HD Dialysis Set, EASY HD Fistula Kit, EASY HD Catheter Set, EASY HD Catheter Kit
SUBMED Brand Microscope Cover
SUBMED Plain Drape, Surgical Drapes, Microscope Cover, CVC Drape, Catheter Drape, Fenestrated Drape, Adhesive Drape
SUBMED Urethral Catheter Set
SubMed
EASY HD Catheter Pouch, SUBMED Catheter Shower Pouch
SUBMED Laceration Treatment Kit
SUBMED CVC Kit
SUBMED I.V. Start Kit
SUBMED Non-woven/Gauze Swab, Non-woven/Gauze Ball,
SUBMED Endoscopy Kit
SUBMED Wound Pad, Pressure Bandage, Plasters
Plaster
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device