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M.Tuberculosis Whole Blood/Serum Test
EUDAMEDClass IVD General (EU MDR)
Ref R09-116
Identity
- Device Name
- M.Tuberculosis Whole Blood/Serum Test EUDAMED
- Model / Reference
- R09-116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571809026 EUDAMED
- Basic UDI-DI
- B-06941571809026 EUDAMED
- EMDN Code
- W0105090199 BACTERIOLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
M.Tuberculosis Whole Blood/Serum Test by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06941571809026 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020607
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 308cf341-f897-4672-82c8-38921581d86f 61 fields · synced Jul 15, 2026