Results 1 to 6 of 6

Thread: FDA/CDRH variance and accession number to USA

  1. #1
    Join Date
    Mar 2014
    Posts
    72

    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
    Join Date
    Jul 2010
    Location
    Wilmington, DE
    Posts
    6,202

    Default

    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...

  3. #3
    mixedgas's Avatar
    mixedgas is offline Creaky Old Award Winning Bastard Technologist
    Infinitus Excellentia Ion Laser Dominatus
    Join Date
    May 2007
    Location
    A lab with some dripping water on the floor.
    Posts
    9,890

    Default

    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.
    Qui habet Christos, habet Vitam!
    I should have rented the space under my name for advertising.
    When I still could have...

  4. #4
    Join Date
    Mar 2014
    Posts
    72

    Default

    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.

  5. #5
    Join Date
    Mar 2014
    Posts
    72

    Default

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

  6. #6
    Join Date
    Mar 2014
    Posts
    72

    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

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •