WODE Bio Manufacturing

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Quality & documentation

Evidence that stays inside its real scope.

For every enquiry, we align product specification, traceability, packaging information and destination-market requirements with the supply route you choose.

Request document reviewVerify QMS reference

Quality route

Documents before claims

Product specification

We align product family, formula direction, intended use, pack format and manufacturing boundary before a quotation is finalized.

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Batch and supply review

Traceability, release checkpoints and agreed documentation are discussed according to the finished, semi-finished or bulk supply model.

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Destination preparation

Language, label content, product claims, importer responsibilities and market-specific requirements are confirmed per destination.

Review market
NEWSCEN diagnostic portfolio

Document references, interpreted correctly.

01
WODE and NEWSCENWODE produces the NEWSCEN-branded diagnostic portfolio. Documentation references are identified exactly as they appear in the supplied records.
02
EU IVDR QMS referenceSupplied certificate V13 095791 0013 Rev. 00 names NewScen Coast Bio-Pharmaceutical Co., Ltd. as the certificate holder and manufacturer. It concerns the quality-management-system scope stated in the record under EU IVDR 2017/746, Annex IX Chapter I.
03
Validity and notified bodyThe supplied record shows validity from 08 August 2025 to 07 August 2030 and identifies TUV SUD Product Service GmbH, notified body 0123. The public verification link above is provided for the reference number.
04
Scope mattersA quality-system certificate is not a product-specific approval for every WODE or NEWSCEN item, claim or destination. Final status is confirmed for the product and country under discussion.
Quality documentation review for a diagnostic product enquiry
Qualified document review before a commercial commitment

Portfolio-specific discussion

What can be reviewed for qualified enquiries

PortfolioReference available from supplied recordsCommercial next step
NEWSCEN HIV (1+2)EU IVDR QMS certificate reference V13 095791 0013 Rev. 00 for the stated manufacturer and scope.Confirm product, destination, requested documents and channel qualification.
NEWSCEN TP antibodySupplied RPS/560/2022 registration record. Treat this as documentation for review, not as a blanket current CE or IVDR product certificate.Confirm the current regulatory route and market availability before any quotation or claim.
Adult wellness portfolioProduct specification, packaging information, batch and export discussion according to the selected supply route.Align formula, label, documentation and destination requirements in the RFQ.

Document sharing

No invented certificate gallery

We do not display fabricated certificate images. For qualified business enquiries, WODE can identify the relevant document reference, scope and destination-market questions before sharing the appropriate commercial documentation through the agreed route.

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Need bulk or semi-finished supply?

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