Regulatory & Quality Documentation
KIRAY Medical coordinates product-specific regulatory and quality documentation for international medical device procurement. Documentation is reviewed according to the selected product, configuration and destination market before commercial commitment.
Documentation We Can Coordinate
A focused review of the records relevant to your procurement project.
FDA / US Regulatory Records
Verified FDA 510(k) records are available for selected intermittent catheter configurations. Exact supplied-model mapping is required.
Contact UsCE / EU MDR Documentation
Current certificate validity, applicable product scope and EU Declaration of Conformity are confirmed before documentation is supplied for commercial or registration purposes.
Documentation availability to be confirmed.
Contact UsISO 13485 Quality Documentation
Quality-management-system documentation relevant to the applicable manufacturing supply chain can be provided for verification where available.
Documentation availability to be confirmed.
Contact UsProduct & Export Documentation
Specifications, sterilization information, labeling and export documents are reviewed for the requested product and destination. Availability and acceptance are confirmed case by case.
Product-Specific Verification
A manufacturer's regulatory record is not a blanket authorization for every product, configuration, private-label package or destination market.
| Product | US regulatory records | CE / quality documentation |
|---|---|---|
| Hydrophilic Intermittent Catheter | Verified Record Available Selected configurations only. Model Mapping Required. | Documentation Under Review Documentation availability to be confirmed. Contact Us |
| Ready-to-use Intermittent Catheter | Verified Record Available Selected configurations only. Model Mapping Required. | Documentation Under Review Documentation availability to be confirmed. Contact Us |
| Hydrophilic Ureteral Access Sheath | Not Yet Confirmed No product-specific clearance reference confirmed for this review. | Documentation Under Review Documentation availability to be confirmed. Contact Us |
| Hydrophilic Coated J Type Ureteral Stent | Not Yet Confirmed No product-specific clearance reference confirmed for this review. | Documentation Under Review Documentation availability to be confirmed. Contact Us |
What We Verify
Before documentation is relied upon, KIRAY reviews, where applicable:
- Product and model
- Material and size
- Configuration and packaging
- Destination market
- Certificate validity
- Applicable product scope
- Declaration of Conformity
- Regulatory record applicability
- Labeling requirements
- OEM / private-label implications
Important Regulatory Note
KIRAY Medical acts as a medical device supply and export partner. Regulatory certificates, registrations or clearances relating to supplied products may be held by the applicable legal manufacturer or other responsible economic operator. KIRAY does not present manufacturer-held documentation as certification issued to KIRAY.
FDA registration and device listing do not constitute FDA approval. Where a 510(k) record is referenced, applicability must be confirmed for the specific product and configuration.
ISO 13485 documentation relates to the applicable manufacturing quality system; it is not certification held by KIRAY Medical.
Full documentation and relevant legal-manufacturer information are supplied to qualified buyers after KIRAY's manual review, subject to availability and applicable disclosure requirements. Original regulatory documents are not altered or relabeled.
Need documents for your market?
Tell us the product, configuration and destination country. We will review the applicable documentation before providing a commercial proposal.