United States
FDA establishment registration and device listings
Registration and listing do not mean FDA approval, clearance or endorsement. Current database status is rechecked before controlled release.
Quality system · Regulatory records · Testing
Controlled evidence, matched to product and market.
The public site presents the framework. Qualified buyers receive controlled copies matched to the legal entity, manufacturing site, product and target market.
Evidence index
Records we hold, stated with their scope.
Original certificates and database records are not reproduced publicly. Each record below remains subject to current-status and project-scope review.
| Record | Evidence held | Scope | Buyer note | |
|---|---|---|---|---|
| Quality system ISO 13485:2016 | Certificate record 117 26 MD 0100 R0 00 | Manufacturing site and certificate scope | Current validity checked before release | |
| U.S. regulatory status FDA establishment registration | FY2026 registration 3031170295 · device listings D531100–D531104 | Relevant listed families | Registration is not approval, clearance or endorsement | |
| EU documentation EU MDR Class I Declaration of Conformity | For applicable product families | Applicable mapped product families | Entity, label and model match required | |
| Material testing ISO 10993-23:2021 | Skin-irritation report SSMT-R-2025-17620-01B | Mapped material / product configuration | Not a blanket claim for every SKU |
Relevance is confirmed by legal entity, model, material, labeling, intended market and current validity before any controlled copy is released.
Compliance by market
The relevant framework depends on the destination market.
No single document set applies everywhere. During project review we map the record set to the legal entity, model, materials, labeling and intended market.
European Union
EU MDR Class I Declaration of Conformity
Applicable to mapped product families and confirmed against legal entity, labeling and destination-market scope during review.
Other markets
ISO 13485 QMS, ISO 10993 testing, country registration
Documentation is mapped to the specific product, material and market during qualified project review.
Qualified review package
Evidence assembled around the actual product.
A certificate by itself is not a product file. We align company, site, quality system, model, materials, labels and destination-market requirements before release.
01
Legal entity
Business license, site identity and responsible-party information.
02
Quality system
Certificate scope, issuer, validity and manufacturing-site match.
03
Product mapping
Model, materials, intended use, labeling and applicable declarations.
04
Market status
Destination-market registration or listing information and current checks.
05
Testing
Relevant material or product reports linked to the proposed configuration.
06
Release file
Approved specification, inspection criteria, artwork and traceability records.
Project-specific evidence