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
Phone
757 2240177

Products

Device Name Product Code
Electrode, Electrocardiograph, Multi-Function MLN
Transducer, Ultrasonic, Diagnostic ITX
Lubricant, Personal NUC
Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
Media, Coupling, Ultrasound MUI
Lubricant, Patient KMJ
Anti Fog Solution And Accessories, Endoscopy OCT

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