Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020777588

FEI Number

3020777588

Entity Name

S & Mohr America, S.A. DE C.V.

City/State/Country

ESTADO DE MEXICO Ciudad de Mexico, MX

Establishment Address

CIRCUITO DE LA INDUSTRIA PONIENTE LOTE 10 C, PARQUE IND. EL CERRILLO, ESTADO DE MEXICO Ciudad de Mexico 52000, MX

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Altech Meditera 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 Meditera Altech 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 Altech TRACHEOSTOMY FILTER WITH HME PAPER BC21090- Standard Breathing Circuit with Trach BC21281 Breathing Circuit Custom Trach Meditera Altech Meditera Altech Meditera Meditera Altech SAPPHIRE INFUSION PUMP Bubble Kit Bubble CPAP Seattle PAP Plus BHF 104 Administration (IV) Set ErgoStar AMT5M Size 5 Anesthesia Mask AMT4M Size 4 Anesthesia Mask AMT6M Size 6 Anesthesia Mask Meditera AMT3M Size 3 Anesthesia Mask Altech 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 Meditera Altech

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2007-04-05
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2007-04-05
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-04-05
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2007-04-05
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2007-04-05
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2010-12-14
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2010-12-14
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
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2018-11-13
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2013-07-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-11-25
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2015-03-06
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2007-04-05
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2020-07-08
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2007-04-05

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
3006534321	Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.	Tire Izmir, TR

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-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

Similar Registrations

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9613910	NARANG MEDICAL, LTD.	New Delhi, IN
3003898360	Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020777588. Last updated year: 2026. Please use registration number 3020777588 when referencing this establishment in official correspondence.