Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006534321

FEI Number

3006534321

Entity Name

Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.

City/State/Country

Tire Izmir, TR

Establishment Address

Ibni Melek Mah., Organize Sanayi Bolgesi, Tire Izmir 35900, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. (Owner Number: 9099982)

Owner / Operator Contact Address

Ibni Melek Mah., Organize Sanayi Bolgesi, Tire, TR-35 35900, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192563

PMA Number

N/A

All Registered Proprietary Names

Altech Meditera SAPPHIRE ADMINISTRATION SET Altech Meditera AMT5M Size 5 Anesthesia Mask AMT4M Size 4 Anesthesia Mask AMT6M Size 6 Anesthesia Mask Meditera AMT3M Size 3 Anesthesia Mask Altech Altech Meditera Altech 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 Meditera Bubble Kit Bubble CPAP Seattle PAP Plus Altech Meditera 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2007-04-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-03-19
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2010-12-14
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2007-04-05
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2007-04-05
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-04-05
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2018-11-13
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2010-02-23
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2024-01-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-01-30
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-01-30
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2013-07-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-03-19
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2015-03-19
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2020-07-08
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-09-30
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2023-02-16
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2025-01-10
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-03-29

Official Correspondent

No official correspondent registered.

US Agent Details

KEVIN WALLS Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020777588	S & Mohr America, S.A. DE C.V.	ESTADO DE MEXICO Ciudad de Mexico, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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3021039857	UAB Intersurgical	Visaginas Salcininkai, LT
3016734145	CREATE BIOTECH CO., LTD.	Taoyuan City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006534321. Last updated year: 2026. Please use registration number 3006534321 when referencing this establishment in official correspondence.