Notified Body
NB 0805
🇦🇺 Australia
THERAPEUTIC GOODS ADMINISTRATION
136 Narrabundah Lane, Symonston, Australia
View on EUDAMED
Updated Nov 11, 2021
Certificates
2
Valid
0
Expiring < 6mo
0
Expired
2
Basic UDI-DIs
16
Devices
16
Manufacturers
2
Cert. Types
1
Basic Information
- Address
- 136 Narrabundah Lane, Symonston, Australia
- [email protected]
- Phone
- 61 2 62328296
Regulatory Overview
Regulation
Loading...
Eu Mdd
16
Classification
Loading...
Eu Md Class 2b
15
Eu Md Class 1
1
Device Types
Loading...
Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | MRA Q00068 | Ellex Medical Pty Ltd | May 20, 2016 | |||
| MDD Annex II (excluding section 4) | MRA Q00089 | Cortical Dynamics Limited | May 25, 2024 |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Cortical Dynamics Limited | 🇦🇺 Australia | 1 | 0 | 0 |
| Ellex Medical Pty Ltd | 🇦🇺 Australia | 1 | 0 | 0 |