For international medical brands, pharmacies, and distributors importing adhesive tapes, nasal strips, and wellness patches into the European Union and global markets, regulatory transparency is no longer optional—it is the prerequisite for market entry.

Under the European Union Medical Device Regulation (EU MDR 2017/745), manufacturer legitimacy, product traceability, and regulatory compliance must be verifiable across public databases before goods clear customs or enter retail shelves. Quanzhou Honglinkai New Material Co., Ltd. (HLK) is fully registered and verified in the official European Database on Medical Devices (EUDAMED), providing our global OEM/ODM partners with end-to-end compliance backing.

1. Official EUDAMED Registration: Actor ID & SRN Verification

EUDAMED is the centralized secure database established by the European Commission to ensure high standards of safety and quality for medical devices. Under the Economic Operators module, HLK has been assigned an official Single Registration Number (SRN):

  • Actor ID / SRN: `CN-MF-000049679`
  • Role: Manufacturer (China)
  • Actor / Organisation Name: Quanzhou Honglinkai New Material Co., Ltd.
  • National Trade Register (USCI): `91350502MABUTIXC95`
  • Registered Address: No 299, Xingxian Road, Licheng District, Quanzhou City, Fujian Province, 362000, China
  • Official Website: https://www.hlktape.com/
  • PRRC (Person Responsible for Regulatory Compliance): Fully designated and documented under EU MDR requirements

You can verify our official EUDAMED economic operator filing directly via the European Commission EUDAMED Public Search Page.

Official European Commission EUDAMED registration screenshot for Quanzhou Honglinkai New Material Co., Ltd. SRN CN-MF-000049679

2. Authorised Representative (EC-REP) & Spanish Competent Authority Oversight

Non-EU manufacturers must mandate a certified European Authorized Representative (EC-REP) located within an EU member state. HLK's mandated European Representative is officially recorded in EUDAMED and supervised by the national Competent Authority:

  • Authorized Representative (EC-REP): HUMISS TRADING S.L. (`ES-AR-000040177`)
  • EC-REP Address: Calle Luis Buñuel 12, 28018 Madrid, Spain
  • Mandate Validity: Active multi-year mandate through 2030
  • Competent Authority: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, Spain

This legal architecture ensures that all technical documentation, CE conformity declarations, and post-market surveillance systems comply strictly with EU health authorities and Spanish AEMPS registration standards.

3. UDI-DI, GS1 Barcodes, and Traceability Registration for Export Clients

Global supply chain standards require rigorous Unique Device Identification (UDI). For B2B buyers developing private-label medical tapes, sports athletic tapes, or nasal strips, HLK provides complete traceability and identifier registration support:

  • UDI-DI & Basic UDI-DI Assignment: Structuring compliant device identifiers tied to product models and packaging levels under EU MDR and US FDA UDI systems.
  • GS1 Standards & ISO Barcodes: Generating standard GS1-128, EAN-13, and ISO/IEC-compliant 2D DataMatrix / QR codes for seamless inventory scanning, logistics tracking, and automated retail checkout.
  • Custom Packaging Integration: Printing certified UDI barcoding, batch numbers (LOT), manufacturing dates, and sterilization/expiry markers directly onto primary foil pouches, inner boxes, and master cartons.
  • Importer Linking: Facilitating European importer registrations linked directly to our manufacturer SRN in EUDAMED.

4. Transparent Dual-Platform Verification: Europa.eu & HumanMade.tools

To give purchasing managers, regulatory auditors, and customs clearance agents instant access to authenticated credentials, HLK credentials can be independently reviewed across two public platforms:

  1. Official EU Regulatory Portal: The European Commission EUDAMED Database provides the official legal proof of economic operator standing under EU MDR 2017/745.
  2. Digital Certificate & Supply Chain Verification: Our verified credentials and qualification dossier can also be reviewed through the decentralized qualification portal at HumanMade.tools Public Registry.

5. Comprehensive Quality & Regulatory Framework

EUDAMED compliance builds upon HLK's existing manufacturing foundation since 1993, backed by international quality management and biocompatibility certifications:

  • ISO 13485:2016 Medical Devices Quality Management System (`RZ7530335`)
  • ISO 9001:2015 Quality Management System (`98526Q00122R053`)
  • ISO 10993 Biocompatibility Suite: ISO 10993-5 (Cytotoxicity MTT test), ISO 10993-10 (Skin Sensitization), and ISO 10993-23 (Skin Irritation) passed via accredited laboratories (CTI / Pony)
  • FDA Device Facility & MoCRA Cosmetics Registrations

You can inspect our complete certificate wall and test reports anytime on our dedicated Product Documents & Certifications page.

Partner with a Verified Medical OEM Manufacturer

Whether you are launching private-label Mouth Tape or Nasal Strips in European pharmacies or expanding across North American retail channels, HLK provides the regulatory stability and manufacturing agility you need.

Contact our regulatory and export specialists at `salesmanager@hlktape.com` or via WhatsApp at `+86-19805957675` to request sample packs, technical documentation, or customized UDI registration support.