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Iso 13485 Equipment & Supplies

254 equipment items found

Cadex - Custom ISO 13485 Battery Packs

Cadex - Custom ISO 13485 Battery Packs

Manufactured by:Cadex Electronics Inc.   based inRichmond, BRITISH COLUMBIA (CANADA)
Cadex specializes in the design and manufacture of battery packs and chargers. Combining these two capabilities enables us to provide you with a one-stop solution. The most important benefit is matching battery and charger to improve battery performance and extend service life, an improvement that cannot be realized with separate designs. Cadex has been providing battery charging and diagnostic ...
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Comofi-Medtech - Model SF1 - Safety Gown

Comofi-Medtech - Model SF1 - Safety Gown

Manufactured by:Comofi Medtech Pvt. Ltd.    based inBangalore, INDIA
Kit Content: Safety gown. 3-ply surgical Mask. Anti fog ...
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Comofi-Medtech - Model NT- ConnectTM - Mask

Comofi-Medtech - Model NT- ConnectTM - Mask

Manufactured by:Comofi Medtech Pvt. Ltd.    based inBangalore, INDIA
Unmask You Expressions: Get Social with Expressions. 100% safety guaranteed. Identify and ...
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Comofi-Medtech - Model EyePro - Goggle

Comofi-Medtech - Model EyePro - Goggle

Manufactured by:Comofi Medtech Pvt. Ltd.    based inBangalore, INDIA
Zero power and well fitting. Anti Fog coated and scratch resistant. Ergonomic Fit. Flexible frame to easily fit all face ...
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Medoject - Blunt Fill Needles

Medoject - Blunt Fill Needles

Manufactured by:Chirana T. Injecta, a.s.   based inStará Turá, SLOVAKIA
According to EN, ISO standards - Quality management certified according to EN ISO 13485:2016 - CE ...
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AHA - Model Fit 20 - Hyperbaric Chambers

AHA - Model Fit 20 - Hyperbaric Chambers

Manufactured by:AHA Hyperbarics GmbH   based inVienna, AUSTRIA
Working pressure of the chamber: 200 kPa (2.0 bar, 2.0 ATA or 15 psi). Manufactured: in accordance with EN ISO 13485:2016 quality management system ...
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Medinorm - Catheters & Probes

Medinorm - Catheters & Probes

Manufactured by:MEDINORM Medizintechnik GmbH   based inSpiesen-Elversberg, GERMANY
Medinorm produces exclusively in Germany. In our modern production facility that is certificated to DIN ISO 13485: 2016 standards, our highly qualified personnel develop and produce quality medical ...
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Medinorm - Medical Suction Set

Medinorm - Medical Suction Set

Manufactured by:MEDINORM Medizintechnik GmbH   based inSpiesen-Elversberg, GERMANY
Medinorm produces exclusively in Germany. In our modern production facility that is certificated to DIN ISO 13485: 2016 standards, our highly qualified personnel develop and produce quality medical ...
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TALI MEDICAL - Model 700/500 - Surgical Lights

TALI MEDICAL - Model 700/500 - Surgical Lights

Manufactured by:TALI MEDICAL   based inIstanbul, TURKEY
Model:TM 700/500 Surgical Lights, Brightness: 700mm lamphead: 40000-160000lux, 500mm: 40000-120000lux, Color Temperature: 4000-5000K, CRI over 90, Work Voltage: AC100-240V, 50Hz/60Hz, Spot Diameter:120-300mm, Osram Led Light Source + CE + ISO 13485 + ISO ...
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SynerMag - Alloys- Extruded Bar

SynerMag - Alloys- Extruded Bar

Manufactured by:Luxfer MEL Technologies   based inManchester, UNITED KINGDOM
Our development and manufacture is the ISO 13485 quality system, this is a requirement for future medical device regulations. Our dedicated facility offers high quality material and process control, this lowers customers risk. We can support programmes from kg to tonne; scalability and capability to support programmes through to success. ...
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Model ISO 13485 - Medical Devices

Model ISO 13485 - Medical Devices

by:Qualityze Inc   based inTampa, FLORIDA (USA)
Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ...
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TALI MEDICAL - Model 700/500 - Surgical Lights with Built-in Camera System

TALI MEDICAL - Model 700/500 - Surgical Lights with Built-in Camera System

Manufactured by:TALI MEDICAL   based inIstanbul, TURKEY
Model:TM 700/500 Surgical Lights With Built-in Camera System, Brightness: 700mm lamphead: 40000-160000lux, 500mm: 40000-120000lux, Color Temperature: 4000-5000K, CRI over 90, Work Voltage: AC100-240V, 50Hz/60Hz, Spot Diameter:120-300mm, Osram Led Light Source + CE + ISO 13485 + ISO ...
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Controls

Controls

Manufactured by:RECIPE Chemicals + Instruments GmbH   based inMUnchen, GERMANY
Manufacturing, lyophilisation, labelling and packing are carried out in our Munich facilities. Our internal QM-system (certified in accordance EN ISO 13485) and regularly recurring external quality control programs and guarantees the high quality of our products. ...
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Adult Clamp Electrode

Adult Clamp Electrode

Manufactured by:Biometric Cables   based inChennai, INDIA
Technical Specifications: Category: ECG, Certifications: ANSI/AAMI EC 53:2013,ISO 13485:2016,ISO 10993-1, 5, 10:2009 & RoHS Compliant, Latex-free: Yes, Clamp Material: Standardized designed Clamps with Excellence Quality materials., Clamp Color Code: IEC(Also Applicable in AHA), No. of Clamp: 4, Packaging Type: Corrugated Box, Packaging Unit: ...
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X-Tech - Model LFS 1 - Fixed X-Ray Machine with Horizontal Bucky Table

X-Tech - Model LFS 1 - Fixed X-Ray Machine with Horizontal Bucky Table

Manufactured by:X-Tech Medical Systems Private Limited   based inKolkata, INDIA
Input Supply: 230 VAC, 50/60Hz. mA (MAX): 25 - 100 mA. kVp (MAX): 100 kVp. Control: APR / Manual. Display: Digital LCD (kVp / mA / mAs). TUBE: Stationary. Approved: CE, FDA, BIS, AERB, ISO 9001, ISO 45001, ISO 13485, ISO 14001, ISO ...
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Traceability Surface Treatment

Traceability Surface Treatment

Manufactured by:Selenium Medical   based inLa Rochelle, FRANCE
We offer high-precision laser marking validated as per IQ OQ PQ PPQ principles, in accordance with the requirements of ISO 13485 and 21 CFR820s. Our team is capable of marking all types of metallic (titanium, stainless steel, etc.) and polymeric (PEEK, etc.) materials. Our expertise in this process makes it possible to produce marking of different sizes, ...
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LW Scientific ReadyWarm - Model FWL-04PL-BTD3 - Warm Working Station

LW Scientific ReadyWarm - Model FWL-04PL-BTD3 - Warm Working Station

Manufactured by:LW Scientific   based inLawrenceville, GEORGIA (US) (USA)
The Ready Warm features all stainless steel and aluminum construction with a precision digital temperature controller, and is made in LW Scientific’s ISO 13485:2016 certified factory in Atlanta, GA. ...
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AHA - Model Flex 20 V2 - Medical Hyperbaric Chambers

AHA - Model Flex 20 V2 - Medical Hyperbaric Chambers

Manufactured by:AHA Hyperbarics GmbH   based inVienna, AUSTRIA
Working pressure of the chamber: 200 kPa (2.0 bar, 2.0 ATA or 15 psi). Certificate: Class IIb Medical Device (MDD 93/42/EEC). Manufactured in accordance with EN ISO 13485:2016 quality management system standard. Designed according to EN 14931:2006 ...
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MAXgene - Model 26406-1 - GMP Transfection Reagent

MAXgene - Model 26406-1 - GMP Transfection Reagent

Manufactured by:Polysciences, Inc.   based inWarrington, PENNSYLVANIA (USA)
MAXgene GMP capitalizes on the efficiency and scalability of Polysciences’ PEI MAX while adding the validation process and regulatory components necessary for moving into clinical and commercial manufacturing. It is manufactured in accordance with cGMP under an ISO 13485 Quality Management ...
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Diatron - Hematology Reagents

Diatron - Hematology Reagents

Manufactured by:Diatron   based inBudapest, HUNGARY
Diatron hematology systems are comprised of analyzers and barcoded reagents, controls and calibrators. The systems were designed to ensure the highest performance and confidence in results. Diatron is ISO 13485 and ISO 9001 certified which ensures consistent product quality, supply and performance. ...
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