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
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2007-04-05 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2015-03-19 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2010-12-14 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2007-04-05 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2007-04-05 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2007-04-05 |
| Humidifier Nebulizer Kit | OGG | Class 2 | Anesthesiology | No | 2018-11-13 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2010-02-23 |
| Accessories, Pump, Infusion | MRZ | Class 2 | General Hospital | No | 2024-01-30 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2024-01-30 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2013-07-17 |
| Device, Positive Pressure Breathing, Intermittent | NHJ | Class 2 | Anesthesiology | No | 2023-02-16 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-03-29 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2007-04-05 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2022-04-06 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2015-03-06 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2010-12-14 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2007-04-05 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2007-04-05 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2015-03-06 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2007-04-05 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2026-02-03 |
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