Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
๐จ๐ณ China
Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing)
Devices (same UDI-DI)
1
Certificates
1
Countries
9
Notified Bodies
1
Basic Information
- Primary DI
- 06955792731103
- Basic UDI-DI Code
- B-06955792731103
- Reference
- S3050E
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Sansure Biotech Inc.
Additional Description
This product is manufactured by Sansure Biotech Inc..
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070501 | STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPPโฆ.) 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) | No. V1 074552 0011 Rev. 02 | TรV SรD Product Service GmbH | Expired |
Available In Countries
๐ง๐ฌ Bulgaria
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
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