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Category: Regulatory Documents & Certifications for the EU

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Downloads: 18
Information
Part Number 98-0239-XX
Revision E
Document Type RA2
Download Language English
Filename 98-0239-XX-RA2-EN-RevE.docx.pdf
Information
Part Number 98-0600-XX
Revision E
Document Type RA2
Download Language English
Filename 98-0600-XX-RA2-EN-RevE.docx.pdf
Information
Part Number 91-0028-XX
Revision C
Document Type RA2
Filename 91-0028-XX-RA2-EN-RevC.docx.pdf
Information
Part Number 98-0400-XX
Revision E
Document Type RA2
Download Language English
Filename 98-0400-XX-RA2-EN-RevE.docx.pdf
Information
Part Number 98-0068-XX
Revision E
Document Type RA2
Download Language English
Filename 98-0068-XX-RA2-EN-RevE.docx.pdf
Information
Part Number 98-0061-XX
Revision E
Document Type RA2
Download Language English
Filename 98-0061-XX-RA2-EN-RevE.docx.pdf

EU Declaration of Conformity for the SunTech Vet20

Information
Part Number 99-0135-XX
Revision B
Document Type RA2
Filename 99-0135-XX-RA2-EN-RevB.docx.pdf

Declaration of Conformity for the SunTech Vet25.

Information
Part Number 99-0170-XX
Revision B
Document Type RA2
Filename 99-0170-XX-RA2-EN-RevB.docx.pdf

Declaration of Conformity for the SunTech Vet30 (M30A).

Information
Part Number 99-0171-XX
Revision B
Document Type RA2
Filename 99-0171-XX-RA2-EN-RevB.docx.pdf

Declaration of Conformity for the SunTech Vet30 (M30B).

Information
Part Number 99-0172-XX
Revision B
Document Type RA2
Filename 99-0172-XX-RA2-EN-RevB.docx.pdf

Declaration of Conformity for the SunTech Vet30E (M30AE).

Information
Part Number 99-0177-XX
Revision B
Document Type RA2
Filename 99-0177-XX-RA2-EN-RevB.docx.pdf

Declaration of Conformity for the SunTech Vet30E (M30BE).

Information
Part Number 99-0178-XX
Revision B
Document Type RA2
Filename 99-0178-XX-RA2-EN-RevB.docx.pdf

EU Declaration of Conformity for the SunTech Veterinary Blood Pressure Cuffs.

Information
Part Number 98-0400-XX-VET
Revision A
Document Type RA2
Filename 98-0400-XX-VET-RA2-EN-RevA.docx.pdf
Information
Part Number 1
Revision 1
Document Type 1
Filename Manufacturer_Declaration_Article_120_Extension.docx.pdf

Assessment, according to Regulation 2017/745 (MDR) article 120, of the notification dated 16 July 2022 for changes of company address for your quality system certified to LVFS 2003:11, Annex II (Swedish implementation of MDD 93/42/EEC).

Information
Part Number 1
Revision 1
Document Type 1
Filename Letter confirming change 41311047-01-001 SunTech Medical Inc. 2022-09-08_Redacted.pdf
Information
Part Number 1
Revision 1
Document Type 1
Filename T101-2-3-MED-MDR MDD Extension Confirmation Letter_SunTech Medical.pdf

requirements of Regulation (EU) 2017/745 for Medical Devices

Information
Part Number 1
Revision 1
Document Type 1
Filename MDR QMS Cert A9 28620152041 2023-06-07_iEnable.pdf
Information
Part Number 1
Revision 1
Document Type 1
Filename T101-2-3-MED-MDR MDD Extension Confirmation Letter_SunTech Medical0.pdf
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