Certified, registered and open to verify
Every certificate is listed with its number, issuer and validity date, and can be downloaded without a form.
Certificates and registrations
| Document | Number | Issuer | Valid | File |
|---|---|---|---|---|
| ISO 13485:2016 quality management system | Q6 004749 0007 Rev. 00 | TÜV SÜD Product Service GmbH | 30 Apr 2024 – 29 Apr 2027 | |
| US FDA establishment registration | 3002905553 | Verified by Medapproval LLC (US agent) | To 15 Dec 2026 (renewed annually) | |
| CE (EU) · TÜV SÜD confirmation letter, EU MDR transition | CL 004749 0011 Rev. 00 | TÜV SÜD Product Service GmbH, Notified Body 0123 | Transition to 31 Dec 2028 | |
| MDA · Nasopharyngeal airways, latex free (Adjustable Flange and Robertazzi Design) | GA47982324617 | Medical Device Authority, Malaysia | 14 Jun 2023 – 13 Jun 2028 | |
| MDA · Robertazzi Design nasopharyngeal airway, latex | GMD91119286017A | Medical Device Authority, Malaysia | 3 Oct 2022 – 2 Oct 2027 | |
| MDA · Test lung, latex free | GMD68247302817A | Medical Device Authority, Malaysia | 5 Jul 2023 – 4 Jul 2028 | |
| MDA · Racine connector | GMD68432286117A | Medical Device Authority, Malaysia | 3 Oct 2022 – 2 Oct 2027 | |
| MDA · Disposable breathing bag, latex free | GB139321360019 | Medical Device Authority, Malaysia | 27 Nov 2024 – 26 Nov 2029 |
ISO 13485 scope: manufacturing and distribution of sterile and non-sterile nasopharyngeal airways, and non-sterile breathing bags, test lungs and Racine connectors. FDA device listings: reservoir breathing bag, nasopharyngeal airway, breathing circuit. CE confirmation letter: covers the latex-free disposable breathing bag (MDD certificate G2 004749 0002) and the latex-free Robertazzi Design and Adjustable Flange airways (G2S 004749 0003).
Key certificates
100% inspection on every device
Stringent quality control is applied throughout production, with 100% inspection conducted on all devices manufactured. Sterile nasopharyngeal airways are sterilised by irradiation.
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