Device Evidence & Regulatory Status
A regulatory claim is only useful when it names the exact model, manufacturer, market, record type, source and verification date.
SanYuan verifies devices at the model level. A logo, “FDA registered” phrase, certificate image or shared wavelength is not enough.
Status Legend
One “verified” badge is not enough; scope matters.
Exact Match
A current source/document has been matched to the exact model.
One Field Only
For example wavelength, manufacturer or one market registration.
Document Exists
A supplier/document claim is present but not fully matched/reviewed.
Current Record Insufficient
Do not publish the claim as true.
Field Does Not Apply
Use when the status type is genuinely irrelevant.
Historical Record
An older model/document has been replaced.
Find a Device
Search by SanYuan SKU, model, marketed name, manufacturer or market. Nonexistent models never render.
Four Regulatory Systems, Four Different Record Types
Similar words are not interchangeable across markets.
FDA
Establishment registration and device listing do not denote approval, clearance or authorization.
- 510(k), De Novo, PMA or other applicable route where relevant
- FDA does not issue establishment registration certificates
- “FDA certified” is not used as proof
Health Canada
MDALL lists active Class II–IV medical-device licences.
- Class I follows different licensing logic
- MDEL is an establishment licence, not specific-device approval/licence
MHRA
Registration, conformity marking, manufacturer identity, UK Responsible Person and intended purpose are separate fields.
- “registered with MHRA” is not translated into “approved by MHRA”
TGA / ARTG
Unless exempt/excluded, relevant devices generally require ARTG inclusion before supply.
- Australian sponsor is a key legal role
- ARTG entry cannot be transferred to a different SKU by similarity
Why Similar Devices Are Not Enough
Similarity can start a search. It cannot close the evidence gap.
Two Devices May Share
- wavelength
- shell or factory
- product code
- technology name
And Still Differ In
- model and output
- software / emitter count
- intended use / labeling
- applicant / sponsor
- regulatory record
Similarity is a research lead, not proof.
Technical, Clinical & Source Quality
P099 shows the model relationship and regulatory truth; P100 owns detailed test-record architecture.
Device Testing
Wavelength, output/irradiance, electrical safety, laser/radiation safety, EMC, battery, thermal, software and other applicable tests.
Application-Specific
Exact device/model relationship, population, indication, protocol, comparator, outcome, duration and limitations.
Official Regulator
FDA, Health Canada, MHRA/GOV.UK, TGA and exact regulator databases.
Manufacturer / Lab
Exact IFU, technical file, test-lab report or verifiable declaration/certificate.
Discovery Only
Distributor pages, marketplaces and marketing brochures can locate leads but do not override Tier 1/2.
P100 Handoff
Dates, “Not Found” & Corrections
Regulatory status is a dated search result, not a timeless badge.
Verification Date
Every current status should carry a YYYY-MM-DD checked date and source.
Not-Found Policy
Use “We did not verify this status in the sources checked on [date]” rather than declaring a device illegal/unlicensed from an incomplete search.
Corrections & Version History
Keep version, old/new value, reason, source, reviewer and date. Superseded records should remain traceable.
Frequently Asked Questions
The answers deliberately separate establishment, device and market authorization concepts.
Is FDA registration the same as clearance?
No.
Does FDA issue registration certificates?
FDA says it does not.
Does FDA cleared mean approved?
No.
Is a product code the same as a clearance?
No.
What is MDALL?
Health Canada’s active Class II–IV device-licence listing.
Is MDEL the device licence?
No.
Does MHRA registration mean approval?
P099 treats registration and conformity/market status as separate facts.
What is ARTG?
Australia’s register for therapeutic goods, including relevant medical devices.
Can another model’s status be used?
No.
What if a status is missing?
We show the current verification state rather than guessing.
Where are test reports?
Regulator References
Model records should link to the exact official result wherever possible.