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Category: Regulatory Documents & Certifications for the EU

APC/OPD Cuff MDR Declarations of Conformity

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Disposable Cuff MDR Declaration(s) of Conformity

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Downloads: 17

Declaration of Conformity for ABPM Orbit Cuff Model ABPM200 HOT

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Information

Part Number 98-0239-XX

Revision D

Document Type RA2

Download Language English

Filename 98-0239-XX-RA2-EN-RevD.docx.pdf

Declaration of Conformity for All Purpose Cuffs & One Piece Durable Cuffs HOT

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Information

Part Number 98-0600-XX

Revision D

Document Type RA2

Download Language English

Filename 98-0600-XX-RA2-EN-RevD.docx.pdf

Declaration of Conformity for Blood Pressure Hose HOT

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Information

Part Number 91-0028-XX

Revision B

Document Type RA2

Filename 91-0028-XX-RA2-EN-RevB.pdf

Declaration of Conformity for Bravo Mini (Model 250D) HOT

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Information

Part Number 99-0233-XX

Revision D

Document Type RA2

Download Language English

Filename 99-0233-XX-RA2-EN-RevD.docx.pdf

Declaration of Conformity for Disposable Cuffs & SPUKits HOT

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Information

Part Number 98-0400-XX

Revision D

Document Type RA2

Download Language English

Filename 98-0400-XX-RA2-EN-RevD.docx.pdf

Declaration of Conformity for Eclipse (D-Ring) Cuffs HOT

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Information

Part Number 98-0068-XX

Revision D

Document Type RA2

Download Language English

Filename 98-0068-XX-RA2-EN-RevD.docx.pdf

Declaration of Conformity for Orbit-K HOT

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Information

Part Number 98-0061-XX

Revision D

Document Type RA2

Download Language English

Filename 98-0061-XX-RA2-EN-RevD.docx.pdf

Declaration of Conformity for Tango M2 HOT

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Information

Part Number 99-0088-XX

Revision D

Document Type RA2

Download Language English

Filename 99-0088-XX-RA2-EN-RevD.docx0.pdf

Declaration of Conformity for the Oscar 2 (Model 250) HOT

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Information

Part Number 99-0133-XX

Revision D

Document Type RA2

Download Language English

Filename 99-0133-XX-RA2-EN-RevD.docx.pdf

Declaration of Conformity for the SunTech CT40 HOT

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Information

Part Number 99-0131-XX

Revision F

Document Type RA2

Download Language English

Filename 99-0131-XX-RA2-EN-RevF.docx.pdf

Declaration of Conformity for the SunTech Vet20 HOT

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EU Declaration of Conformity for the SunTech Vet20

Information

Part Number 99-0135-XX

Revision A

Document Type RA2

Filename 99-0135-XX-RA2-EN-RevA.docx.pdf

Declaration of Conformity for the SunTech Vet25 HOT

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Declaration of Conformity for the SunTech Vet25.

Information

Part Number 99-0170-XX

Revision A

Document Type RA2

Filename 99-0170-XX-RA2-EN-RevA.docx.pdf

Declaration of Conformity for the SunTech Vet30 (M30A) HOT

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Declaration of Conformity for the SunTech Vet30 (M30A).

Information

Part Number 99-0171-XX

Revision A

Document Type RA2

Filename 99-0171-XX-RA2-EN-RevA.docx.pdf

Declaration of Conformity for the SunTech Vet30 (M30B) HOT

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Declaration of Conformity for the SunTech Vet30 (M30B).

Information

Part Number 99-0172-XX

Revision A

Document Type RA2

Filename 99-0172-XX-RA2-EN-RevA.docx.pdf

Declaration of Conformity for the SunTech Vet30E (M30AE) HOT

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Declaration of Conformity for the SunTech Vet30E (M30AE).

Information

Part Number 99-0177-XX

Revision A

Document Type RA2

Filename 99-0177-XX-RA2-EN-RevA.docx.pdf

Declaration of Conformity for the SunTech Vet30E (M30BE) HOT

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Declaration of Conformity for the SunTech Vet30E (M30BE).

Information

Part Number 99-0178-XX

Revision A

Document Type RA2

Filename 99-0178-XX-RA2-EN-RevA.docx.pdf

MDD - Change Assessment HOT

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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

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<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf0"/> Declaration of Conformity for ABPM Orbit Cuff Model ABPM200 HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf1"/> Declaration of Conformity for All Purpose Cuffs & One Piece Durable Cuffs HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf2"/> Declaration of Conformity for Blood Pressure Hose HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf3"/> Declaration of Conformity for Bravo Mini (Model 250D) HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf4"/> Declaration of Conformity for Disposable Cuffs & SPUKits HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf5"/> Declaration of Conformity for Eclipse (D-Ring) Cuffs HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf6"/> Declaration of Conformity for Orbit-K HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf7"/> Declaration of Conformity for Tango M2 HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf8"/> Declaration of Conformity for the Oscar 2 (Model 250) HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf9"/> Declaration of Conformity for the SunTech CT40 HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf10"/> Declaration of Conformity for the SunTech Vet20 HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf11"/> Declaration of Conformity for the SunTech Vet25 HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf12"/> Declaration of Conformity for the SunTech Vet30 (M30A) HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf13"/> Declaration of Conformity for the SunTech Vet30 (M30B) HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf14"/> Declaration of Conformity for the SunTech Vet30E (M30AE) HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf15"/> Declaration of Conformity for the SunTech Vet30E (M30BE) HOT

<img src="https://suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf16"/> MDD - Change Assessment HOT

Declaration of Conformity for ABPM Orbit Cuff Model ABPM200 HOT

Declaration of Conformity for All Purpose Cuffs & One Piece Durable Cuffs HOT

Declaration of Conformity for Blood Pressure Hose HOT

Declaration of Conformity for Bravo Mini (Model 250D) HOT

Declaration of Conformity for Disposable Cuffs & SPUKits HOT

Declaration of Conformity for Eclipse (D-Ring) Cuffs HOT

Declaration of Conformity for Orbit-K HOT

Declaration of Conformity for Tango M2 HOT

Declaration of Conformity for the Oscar 2 (Model 250) HOT

Declaration of Conformity for the SunTech CT40 HOT

Declaration of Conformity for the SunTech Vet20 HOT

Declaration of Conformity for the SunTech Vet25 HOT

Declaration of Conformity for the SunTech Vet30 (M30A) HOT

Declaration of Conformity for the SunTech Vet30 (M30B) HOT

Declaration of Conformity for the SunTech Vet30E (M30AE) HOT

Declaration of Conformity for the SunTech Vet30E (M30BE) HOT

MDD - Change Assessment HOT