Own Brand Label Medical Device

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Private Labeled Devices with FDA Approval - Medical …

https://medicaldeviceacademy.com/private-labeled-devices-with-fda-approval/

A non-US company would like to distribute under its brand name a device to the US market. The device is manufactured by another non-US manufacturer (OEM) which own a 510K for the device. The distributer has a US agent which also acts as an initial importer for other devices. How to label the device and who … See more

OBL - Own Brand Labelling Medical Devices (MDR 2017/745)

https://easymedicaldevice.com/own-brand-labelling/

Own Brand Labelling or OBL is the action to buy a product that is already finished from another manufacturer and to put your …

Q & A's: What is Medical OEM? What's Own-Brand Labeling?

https://bmpmedical.com/what-is-a-medical-device-oem/

A medical OEM is an acronym for an Original Equipment Manufacturer that produces medical devices. Medical OEMs are an important part of the medical device …

Own brand label manufacturing: what's next? - Thema Med

https://www.thema-med.com/en/2019/04/30/own-brand-label-manufacturing-whats-next/

Own Brand Labelling (OBL) is a marketing route where a manufacturer sells under their own brand an already CE-marked medical device, which they have purchased …

Device Labeling | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Device Labeling | FDA Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops …

Own Brand Labelling - the OEM PLM process - seleon GmbH

https://www.seleon.com/en/regulatory-affairs/own-brand-labelling-the-oem-plm-process/

The PLM approves the medical devices in a simplified procedure under its name. The PLM buys the medical devices from the OEM and markets them as its own …

Labels for Medical Devices | Clin R

https://clin-r.com/labels-for-medical-devices/

The European Union’s Medical Device Regulation (MDR) defines “label” as: “label” means any written, printed, or graphic information appearing either on the device itself, on the …

Conformity Assessment of Own Brand Labelling - Team NB

http://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Recommendation-NB-MED-2_5_5-Rec_5_Conformity_Assessment_of_Own_Brand_Labelling.pdf

Description of “Own Brand Labelling” manufacturer “Own brand labelling” manufacturer means the person or company re-labelling a device with existing CE Marking from a third …

How to Create a Label as per EU MDR 2017/745?

https://easymedicaldevice.com/create-a-label-eu-mdr-2017-745/

Medical Device Labeling Requirements as per EU MDR: If there is no expiration date, manufacturers should include the device’s name and trade name, as …

Private label process for FDA - Medical Devices Group

https://www.medicaldevicesgroup.net/medical-devices/private-label-process-for-fda/

Private label process for FDA < 1 min reading time A company is interested in getting a private label agreement with an OEM to sell a Class II medical device in the USA. The …

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