System control
Mericonn’s official profile states ISO 9001 and ISO 13485 certification and describes controls across R&D, production, supply chain and finished-product inspection. Current certificates remain a pre-launch document request.
Quality
Quality is a system, not a badge wall.
Define the requirement, control the process and verify the exact model evidence before release.
Process evidence
Inspection criteria, work instructions, equipment status and release records should connect to the exact product specification.
Model-level scope
Clearance belongs to named models, intended users and indications—not automatically to an entire category or catalogue.
Control points
Build evidence into each handoff.
The precise methods and acceptance criteria belong in the released specification and quality plan.
- IncomingSupplier and material controls
- In processAssembly and critical-process checks
- FunctionalModel-specific performance verification
- ReleaseFinished-product inspection and records
- ChangeReviewed revisions and traceable implementation
Primary-source records
Three FDA clearances, with exact boundaries.
Additional public verification
Product records beyond a single market.
These primary-source records add useful context, but each remains tied to its named product, date and jurisdiction.
Brazil · ANVISA
Registration 10237619026
FD100 and FD200, Class II record effective from 10 April 2023.
China · Guangdong MPAUN201 sampling result
Published medical-device sampling record reports a conforming result for UN201.
China · Guangdong MPABP401 sampling result
Published medical-device sampling record reports a conforming result for BP401.
Russia · RoszdravnadzorRZN 2024/23716
Public register entry covers UN201 and UN209; status should be rechecked at decision time.
Need a document set for evaluation?
Tell us the exact product model and destination market so the team can route the relevant current evidence.
Request model documents