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Legal Manufacturer


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17:41 Aug 31, 2011
English to Dutch translations [PRO]
Medical - Medical: Instruments / Medical Device
English term or phrase: Legal Manufacturer
This is a phrase that is commonly entered next to the CE symbol for Manufacturer.
Should this be translated?
Is there any official term for this phrase that goes with the symbol?
The target country is the Netherlands.
Pro-Active
United States
Local time: 14:04

Summary of reference entries provided
Reference
Josephine Isaacs
wettelijke fabrikantBarend van Zadelhoff

  

Reference comments


6 hrs peer agreement (net): +1
Reference: Reference

Reference information:
Perhaps this helps:

Het is wettelijk vastgelegd dat fabrikanten van medische hulpmiddelen zichzelf en hun producten moeten laten registreren bij het bevoegd gezag van de lidstaat waarin ze gevestigd zijn. Behalve voor fabrikanten, geldt dit ook voor in Nederland gevestigde Europees gemachtigden van fabrikanten van buiten de EU.


    Reference: http://www.igz.nl/onderwerpen/geneesmiddelen-en-medische-tec...
    Reference: http://www.ce-marking.com/what-is-a-manufacturer.html
Josephine Isaacs
Australia
Specializes in field
Native speaker of: Native in DutchDutch, Native in EnglishEnglish
PRO pts in category: 4

Peer comments on this reference comment (and responses from the reference poster)
agree  Barend van Zadelhoff: I think your references are pertinent to the question.
6 hrs
Login to enter a peer comment (or grade)

7 hrs peer agreement (net): +2
Reference: wettelijke fabrikant

Reference information:
I found this in an IFU for: The Xcela Power Injectable Peripherally Inserted Central Catheter (PICC).

In connection with the relevant symbol.

I read Josephine's references and 'wettelijke' was what came to mind and then I checked. I think 'wettelijke fabrikant' is the correct translation

Xcela™
Power Injectable PICC

Legal Manufacturer

Fabricante legal

Fabricant légal

Berechtigter Hersteller

Fabbricante legale

In Dutch: Wettelijke fabrikant

法定製造元

http://navilyst.com/Products/downloads/dfu_xcela_01_us.pdf

Barend van Zadelhoff
Netherlands
Native speaker of: Native in DutchDutch
PRO pts in category: 36

Peer comments on this reference comment (and responses from the reference poster)
agree  analytical
5 hrs
  -> Dank je wel.
agree  Josephine Isaacs: Ja, ik zou het ook vertalen. Wettelijke fabrikant klinkt goed.
9 hrs
  -> Dank je wel. Ter bevestiging had ik jouw referenties wel nodig.
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