SHININGLIONEU
European Union
EU MDR Class I device documentation, European Authorized Representative notification and technical documentation review for listed product families.
Quality · Compliance · Verification
Evidence Buyers Can Verify. Quality They Can Rely On.
SHLION combines medical-device quality systems, market-specific documentation, product testing and controlled manufacturing to support distributors, healthcare projects and OEM partners worldwide.
What applies where
Documentation Organized By Market Purpose
A certificate is only useful when its scope, product and target market match the purchase. This overview helps buyers identify the right starting point.
US
United States
FDA establishment registration and device listing evidence for FY2026. Product listing is not the same as FDA product approval.
CN
China
NMPA Class II medical device registrations and manufacturing authorization covering specified electric medical bed models.
QMS
Global Buyer Review
ISO 13485 and ISO 9001 support supplier qualification, quality audits and procurement due diligence across multiple markets.
Core documentation
Certificates & Regulatory Evidence
Each item below states what the document demonstrates—and what it does not. Click a document image to inspect the preview.
ISO 13485:2016
Medical-device quality management system covering the design and development, manufacture and service of electric and manual medical beds.
EU MDR Notification & EC Representative
European Authorized Representative notification under Regulation (EU) 2017/745 for electric beds, manual beds, examination beds/accessories and medical trolleys.
FDA Establishment Registration & Device Listings
FY2026 establishment registration notice with listings for medical beds, trolleys, cabinets, mattresses, accessories, patient hoists and other product categories.
EU Technical Documentation Review
Voluntary review of technical documentation against EU MDR Annexes II and III for listed Class I electric medical bed models.
ISO 9001:2015
General quality management system covering the design and development, manufacture and service of electric and manual medical beds.
NMPA Electric Medical Bed Registrations
China Class II product registrations for specified electric medical bed models intended to support adult patients during diagnosis, treatment or monitoring.
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Regulatory scope matters
Documents shown here do not automatically apply to every SHLION model, configuration or destination. Final compliance must be checked against the exact product, intended use, labeling, accessories, market classification and current document version.
Product-level evidence
Testing Beyond The Management System
Management-system certificates qualify the organization. Product reports provide evidence for specific models and specific test programs.
Safety, EMC & Performance Reports
SHLION maintains model-specific reports for buyer review. Full controlled copies are supplied against an identified model and market requirement.
SLD-A51-112
Electrical safety test report
Report 220244194, Zhejiang Institute of Medical Device Supervision and Testing, dated 15 Apr 2025.
SLD-A51-112
Electromagnetic compatibility report
Report 220244194-D, Zhejiang Institute of Medical Device Supervision and Testing, dated 10 Feb 2025.
MODEL SERIES
Additional performance evidence
Reports are also available for SLD-A31-421, SLS-A21-421, SLS-A21-111, SLS-D30-1 and other identified configurations.
Age-Friendly Product Assessment
AFC-1 certificates evaluate visual communication, physical interaction, cognitive load, safety and error tolerance. They are supplementary usability evidence—not mandatory U.S. market-access certificates.
SLD-A31-421AFC-1 age-friendly assessment
SLD-A51-112AFC-1 age-friendly assessment
In-house validation capability
Testing Equipment For Bed Structure And Movement Checks
Dedicated equipment supports repeatable checks during product development, production verification and model-specific evaluation.
From Function Check To Test Evidence
The facility shown includes bed-mounted test rigs and controlled test platforms used to support product and process verification.
Bed movementSupports repeatable observation of powered bed articulation and mechanism operation.
Structure & loadProvides controlled setups for model-specific frame and support-surface evaluation.
Buyer documentationRelevant test records and third-party reports can be matched to the requested model and market.
Manufacturing control
Quality Built Into The Production Flow
Documentation is supported by controls across materials, assembly, functional checks and export preparation.
01 · INCOMING & STRUCTURE
Material And Frame Control
Material identification, structural fabrication and key-component checks support consistency before final assembly.
02 · ASSEMBLY & FUNCTION
Process And Functional Checks
Assembly checkpoints cover movement, controls, accessories, safety-related functions and finished-product condition.
03 · RELEASE & PACKING
Final Inspection And Export Pack
Final review, identification and transport-ready packing help protect the approved configuration through delivery.
Buyer verification
Request The Right Evidence For Your Project
For reliable due diligence, the document pack should be built around your destination, product model and intended use—not selected from a generic certificate list.
Tell us the destination market
Country or region determines which regulatory evidence should be reviewed.
Confirm model and configuration
Functions, accessories and labeling can change the applicable document scope.
Receive a controlled compliance pack
We provide the relevant current certificates, reports and declarations for procurement review.
Document note: Certificate previews are provided for procurement orientation. Validity, scope and current status should be confirmed from the issuing body or official regulator where applicable. Availability and market acceptance may change; SHLION can provide current controlled copies for project review.