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Thread: FDA/CDRH variance and accession number to USA

  1. #1
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    Laser Warning FDA/CDRH variance and accession number to USA

    A guy ask our UL certificate from USA? And said that no UL, he can't import our laser projector. We just know that FDA certificate is necessary, Is UL also necessary now?

  2. #2
    Bradfo69's Avatar
    Bradfo69 is offline Pending BST Forum Purchases: $47,127,283.53
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    No. Not required.

    It's a good idea though to get a safety review and certification from Underwriters Laboratories but, they are not the only organization that actually fulfills this role so, I don't know of any requirement that it HAS to be UL.

    Google it....
    PM Sent...

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    Quote Originally Posted by Bradfo69 View Post
    No. Not required.

    It's a good idea though to get a safety review and certification from Underwriters Laboratories but, they are not the only organization that actually fulfills this role so, I don't know of any requirement that it HAS to be UL.

    Google it....

    NFPA 70, The US National Electric Code, specifies several possible approvals besides UL.

    If the purchaser works for a big company, he is probably required to have a UL or CSA tag on it, or it will probably NOT make it past shipping and receiving.

    My last employer nearly lost a contract because we shipped 139 power cords from Europe that had a DIN (German) and CSA (Canada) but not UL approval to a national lab. Corporate and Government need that approval for their hardware. The rest of us should insist upon it, because if a un-certified box causes a building fire, in some cases the insurance may not pay.

    We bought 139 twenty foot long cords with UL approval. That made the customer happy.

    Most places in the USA will accept a CSA approval.

    Steve
    Last edited by mixedgas; 06-23-2015 at 06:23.
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  4. #4
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    Thank your reply. We also checked about the UL certificate, laser projector is not listed in it. Household appliances, medical facility, computer etc equipment and some cables, fuse, switch etc are listed and rerquired.

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    The cable are listed in UL certificate. No requirements for laser projector.

  6. #6
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    Default Our FDA variance and accession number

    Quote Originally Posted by ablelaser01 View Post
    A guy ask our UL certificate from USA? And said that no UL, he can't import our laser projector. We just know that FDA certificate is necessary, Is UL also necessary now?
    We got the FDA veriance in 2009, and then we submit the annual report to get the newest accession number each year.
    Attachd the variance and newest accession number.
    Click image for larger version. 

Name:	Pages from Guangzhou Able Entertainment LDS 04072010 Variance Approval 2009V-0307.pdf 
Views:	17 
Size:	112.2 KB 
ID:	47450

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