Certifications and compliance, verifiable one by one
Four credentials — ISO 13485, EU CE, US FDA and Australian TGA — with issuing body, scope and validity stated item by item, plus a third-party verification path for each.
Issuing body, scope and validity
Exactly what tenders and customs clearance require, laid out as a table.
| Credential | Issuing body | Scope | Validity |
|---|---|---|---|
| ISO 13485:2016 | TÜV Rheinland | Design & development, manufacturing, sales and service | Valid to 2028 |
| CE · EU | TÜV Rheinland · NB 0197 | GD-S200 / S300 / S350 / S450 / S600 / S800 main models | Valid to 31 Dec 2028 |
| FDA · USA | US FDA | Establishment Registration No. 3013237609 | Status Active, publicly verifiable |
| TGA · Australia | Australia TGA | ARTG 527247, Class IIa, manufacturer Foshan Gladent | Held by our Australian subsidiary |
Do not take our word — check the numbers yourself
FDA establishment registration
Look up registration number 3013237609 in the FDA public database — third-party verification without any document from us.
EU CE
Issued by TÜV Rheinland notified body 0197; verifiable with the notified body under the certificate number.
ISO 13485
The system certificate covers design and manufacturing; originals and audit reports can be reviewed during a factory visit.
Australia TGA
ARTG 527247 is searchable in the TGA public ARTG database; the manufacturer is Foshan Gladent.
Need stamped certificates for a tender?
Send an inquiry with the purpose and model, and we will provide stamped scans or paper copies.