FDA Registration Active 🇹🇷 Türkiye

Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.

Reg #: 3006534321 · FEI: 3006534321 · Expires 2026
Products
22
Proprietary Names
85
Establishment Types
5
Classifications
22

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Registration Details

Registration Name
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.
Registration Number
3006534321
FEI Number
3006534321
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Ibni Melek Mah., Organize Sanayi Bolgesi
City
Tire Izmir
Country
TR

Regulatory Submissions

510(k) Number
K141834

Owner / Operator

Firm Name
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.
Operator Number
9099982
Address
Ibni Melek Mah., Organize Sanayi Bolgesi
City
Tire
State
Izmir
Postal Code
35900
Country
TR

US Agent

Business Name
Regulatory Insight, Inc.
Contact Name
KEVIN WALLS
Address
33 Golden Eagle Lane
City
Littleton
State
CO
ZIP
80127
Country
US
Phone
720 9625412

Products

Device Name Product Code
Drain, Tee (Water Trap) BYH
Set, Administration, Intravascular FPA
Support, Breathing Tube JAY
Mask, Oxygen BYG
Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
Humidifier Nebulizer Kit OGG
Mask, Oxygen, Non-Rebreathing KGB
Accessories, Pump, Infusion MRZ
Pump, Infusion FRN
Filter, Bacterial, Breathing-Circuit CAH
Device, Positive Pressure Breathing, Intermittent NHJ
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Set, Tubing And Support, Ventilator (W Harness) BZO
Valve, Non-Rebreathing CBP
Connector, Airway (Extension) BZA
Mouthpiece, Breathing BYP
Bag, Reservoir BTC
Condenser, Heat And Moisture (Artificial Nose) BYD
Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
Mask, Oxygen, Low Concentration, Venturi BYF
Tubing, Pressure And Accessories BYX

Proprietary Names

Altech Meditera SAPPHIRE ADMINISTRATION SET AMT5M Size 5 Anesthesia Mask AMT4M Size 4 Anesthesia Mask AMT6M Size 6 Anesthesia Mask AMT3M Size 3 Anesthesia Mask Standard Breathing Circuit with Face Mask - Child/Adult Small Standard Breathing Circuit with Face Mask - Toddler Standard Breathing Circuit with Mouthpiece Standard Breathing Circuit with Face Mask - Adult Medium Standard Breathing Circuit with Face Mask - Adult Large BC21092- Standard Breathing Circuit with Mouthpiece BC21273- Standard Breathing Circuit with Face Mask- Adult Large BC21087- Standard Breathing Circuit with Face Mask - Toddler BC21086 – Standard Breathing Circuit with Face Mask- Infant BC21089- Standard Breathing Circuit with Face Mask – Adult Medium BC21088- Standard Breathing Circuit with Face Mask – Child/ Adult Small Bubble Kit Bubble CPAP Seattle PAP Plus Set, administration, intravascular BHF 104 SAPPHIRE INFUSION PUMP HME712 - Heat Moisture Exchanger with Filter BACTERIA FILTER WITH SOFT CAP PP BACTERIA HME FILTER PP WITH SOFT CAP WITH FOAM BKM953H-B - Anesthesia Breathing Circuit Kit 31161 - HME with Flex Tubes BV001 - Bacterial Viral Filter BKM953H - Anesthesia Breathing Circuit Kit AL-08021.V001 BV002 - Bacterial Viral Filter MP12062 MP12063 MP12060 MP12061 BC23412 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium BC23400 BiWaze Cough Dual Lumen Circuit With Face Mask - Child BC23394 BiWaze Cough Dual Lumen Circuit With Trach Adapter BC23406 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small BC23387 BiWaze Cough Dual Lumen Circuit With Mouthpiece BC23418 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Small BK289 BiWaze Clear Dual Lumen Circuit With Trach Adapter BK293 BiWaze Clear Dual Lumen Circuit With Face Mask - Child BK291 BiWaze Clear Dual Lumen Circuit - Acute BK909 BiWaze Clear Dual Lumen Circuit With Face Mask - Infant BK902 BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Medium BK287 BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Large BK285 DYNJAA15 GAS SAMPLING LINE 047 ID 10FT MM COEX DYNJAA15-B GAS SAMPLING LINE 047 ID 10FT MM COEX 009118 Disposable 22mm Single Limb (1.8m) 009119 Disposable 15mm Single Limb (1.8m) 005519- 15mm Dual Limb Breathing Circuit 005520- 22mm Dual Limb Breathing Circuit 005060 22 MM BREATHING CIRCUIT / LEAK PORT BK285 BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Large BK280 BiWaze Clear Dual Lumen Circuit With Mouthpiece BK291 BiWaze Clear Dual Lumen Circuit With Face Mask - Child BK287 BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Medium BK293 BiWaze Clear Dual Lumen Circuit With Trach Adapter BK289 BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Small 007616 IPBB BREATHING CIRCUIT (BREAS) 007387 22MM DISPOSABLE BREATHING CIRCUIT WITH EXHALATION VALVE 007857 15 MM DISP PT CIRCUIT W EX VAL TRAA003P AL-12300.V001 CATHETER MOUNT (ALTECH) Leak Port (single pack) VEN004 AB-3010-000/9.V001 EXHALATION VALVE KIT ErgoStar BB1M Anesthesia Breathing Bag, Finish 1L TRACHEOSTOMY FILTER WITH HME PAPER BC21090- Standard Breathing Circuit with Trach BC21281 – Breathing Circuit Custom Trach US-Kits AL-1300-170/5.V002 AL-1100-170/5.V002 AL-1100.V002 AL-1400.V005 BGA7M 71” Anesthesia Breathing Circuit - Pediatric BGE7M 71” Anesthesia Breathing Circuit - Adult BGE9M 94” Anesthesia Breathing Circuit - Adult BGA9M 94” Anesthesia Breathing Circuit - Pediatric Administration (IV) Set INFANT FLOW TUBE, 60CM, SPU

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer) Repack or Relabel Medical Device