Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇦🇺 Australia
Step 2 Plates for STI (16-well)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 09343044002113
- Basic UDI-DI Code
- B-09343044002113
- Reference
- 27112P
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- AusDiagnostics Pty Ltd
Additional Description
Step 2 Plates for STI (16-well)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070501 | STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 003496 0007 | TÜV SÜD Product Service GmbH | Expired |
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