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for Swiss Authorized Representative (CH-REP)
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Company and contact person
Company
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Name
*
First
Last
Function
*
Single Registration Number (SRN) (optional)
Phone
Email
*
Company Details
Country
*
Website / URL
*
Regulatory Compliance Officer (PRRC)
Product
Please let us know how many Technical Documentations and EMDN codes (or GMDN / UMDNS codes) you have.
Number of technical documentations
*
Number of EMDN codes
Class I Products / IVD List/Class A
*
Class Is/Ir/Im Products / IVD List/Class A
*
Class IIa Products / IVD List/Class B
*
Class IIb Products / IVD List/Class C
*
Class III Products / IVD List/Class D
*
(Please note that Effectum CH-Rep AG accepts mandate as the Swiss Authorized Representative for Class III / IVD List/Class D products only in exceptional cases upon thorough assessment of each request.)
URL to the EU/EC Declaration of Conformity
Or Upload the EU/EC Declaration of Conformity
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URL for labeling
Or Upload File
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Please note
Customer must include Effectum CH-Rep AG in its liability insurance. Effectum CH-Rep AG does not guarantee the acceptance of the mandate. Since the Swiss Authorised Representative is jointly liable with the manufacturer for defective products, Effectum CH-Rep AG makes the acceptance of the Swiss Rep mandate dependent on a preliminary verification of the conformity of the medical device, which includes the verification of the technical documentation. We will use your contact details to contact you directly to discuss possible cooperation opportunities now or in the future.
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