FDA Registration
Active
🇹🇷 Türkiye
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUN
Reg #: 3009482034
·
FEI: 3009482034
·
Expires 2026
Products
7
Proprietary Names
33
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUN
- Registration Number
- 3009482034
- FEI Number
- 3009482034
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No: 45/5 Akcaburgaz Mahallesi, MUHSIN YAZICIOGLU CADDESI
- City
- ESENYURT Istanbul
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K101952
Owner / Operator
- Firm Name
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
- Operator Number
- 10038506
- Address
- No: 45/5 Akcaburgaz Mahallesi, MUHSIN YAZICIOGLU CADDESI
- City
- ESENYURT
- State
- Istanbul
- Postal Code
- 34522
- Country
- TR
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2024-07-31 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2011-10-19 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2016-08-17 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2016-05-18 |
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2015-11-06 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2023-02-08 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2021-08-26 |
Proprietary Names
ECG Gel 500 ml
ECG Gel 250 ml
ECG Gel 5000 ml
ECG Gel 1000 ml
Konix Ultrasound gel
Joy Drops
Konix Burn Gel
Konix Sterile Gel
KoniLube Sterile Lubricating Jelly 0.18 oz sachet
GYNOTAL Obstetric Sterile Gel 12 ml
KoniLube Sterile Lubricating Jelly 2 oz
82 gr 113 gr 250 ml 1000 ml
KLY Sterile Lubricating Jelly 2 oz
KONIX SURGICAL LUBRICANT GEL 5G SACHET
KONIX SURGICAL LUBRICANT GEL 3G SACHET
KLY Sterile Lubricating Jelly 4 oz
KLY Sterile Lubricating Jelly 2.90 oz
KLY Sterile Lubricating Jelly 6 G
KLY Sterile Lubricating Jelly 12 G
KoniLube Sterile Lubricating Jelly 2.89 oz
KONIX SURGICAL LUBRICANT GEL 4.25OZ
KLY Sterile Lubricating Jelly 1.48 oz
KONIX SURGICAL LUBRICANT GEL 2OZ.
KoniLube Sterile Lubricating Jelly 0.70 oz Sachet
KLY Sterile Lubricating Jelly 11G
KLY Sterile Lubricant sachet 5 g
KLY Non Sterile Lubricant Jelly 2.5 gr 3 gr 3.5 gr 4 gr 4.5 gr 5 gr 10 gr 42 gr 50 gr 62 gr 82 100 gr 113.4 gr 42 gr
KONIX SURGICAL LUBRICANT GEL 4 oz
KoniLube Sterile Lubricating Jelly 1.48 oz
KoniLube Sterile Lubricating Jelly 0.10 oz Sachet
KoniLube Sterile Lubricating Jelly 4 oz
KLY Sterile Lubricant Jelly 12.5 g
Konix Anti-Fog Solution
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device