Compliance Support for Applicable
Products and Markets
We confirm documentation by product model, intended use, regulatory classification, and destination market. Quality-system certificates, product-specific CE files, FDA registration or listing information, and inspection records are provided only where applicable.
View Our Certificates
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CE Marking
CE marking applies only to products covered by relevant EU legislation. For applicable models, we confirm the required conformity assessment and product-specific documentation before supply to the European Economic Area.
13485
ISO 13485:2016
ISO 13485 specifies quality management system requirements for organisations involved in medical devices. It applies to the activities and scope shown on the certificate and should not be interpreted as blanket certification of every furniture product.
9001
ISO 9001:2015
ISO 9001 covers the quality management activities and scope stated on our certificate, including defined controls from incoming materials through production and final release.
FDA Registration & Device Listing
FDA establishment registration and device listing information is provided only for applicable regulated products. Registration or listing does not mean that the FDA has approved, cleared, certified, or endorsed the facility or product.
SGS Inspection
SGS is the world's leading inspection and certification company. Our pre-shipment inspections are conducted by SGS inspectors at our factory — providing independent, third-party verification of product quality, quantity, and specification compliance before your cargo leaves China.
ISO
EN Standard Testing
Relevant product models may be tested against applicable EN standards, including EN 1335, EN 13761, and EN 527. Test reports and scope are confirmed for the selected model before order.
Compliance documentation prepared in parallel with production
You don't wait for production to finish before paperwork starts. Our compliance team prepares the documentation agreed for the selected products and destination market as the order moves through production.
Market Assessment
We confirm your destination country's regulatory requirements at order confirmation — EU, GCC, U.S., Southeast Asia, or other markets each have specific requirements we map in advance.
Document Preparation
Where applicable, product-specific CE documents, relevant quality-system certificates, test reports, FDA registration or listing information, and inspection arrangements are prepared against the agreed scope.
Pre-Shipment Inspection
SGS or your nominated third-party inspector verifies specification compliance, quantity, and quality at our factory before loading. Inspection reports issued within 48 hours.
Complete Document Pack
The documentation agreed for the order — which may include certificates, test reports, packing lists, shipping documents, and country-specific declarations — is provided with the shipment.
Indicative documentation by product category
Availability depends on the exact model, intended use, regulatory classification, destination market, and current certificate scope. A check mark indicates that relevant documentation may be available; it does not mean every product in the category is CE marked, FDA approved, or certified under ISO 13485.
| Product Category | CE | ISO 13485 | ISO 9001 | FDA Registration / Listing | SGS (on request) |
|---|---|---|---|---|---|
| Hospital / Care Beds | ✓ | ✓ | ✓ | ✓ | ✓ |
| Medical Trolleys & Carts | ✓ | ✓ | ✓ | ✓ | ✓ |
| Nurse Stations | ✓ | ✓ | ✓ | — | ✓ |
| Patient & IV Chairs | ✓ | ✓ | ✓ | ✓ | ✓ |
| Medical Cabinets & Storage | ✓ | ✓ | ✓ | — | ✓ |
| Waiting Room & Visitor Seating | ✓ | — | ✓ | — | ✓ |
| Wash Basins & Sanitiser Units | ✓ | ✓ | ✓ | — | ✓ |
| Custom OEM / ODM Products | ✓ | ✓ | ✓ | On request | ✓ |
Need specific certification documents
before you issue a PO?
Share your destination country and product requirements. Our compliance team will confirm which certificates apply and send copies within one business day.