Identity
- Device Name
- TC Rapid Test Kit EUDAMED
- Model / Reference
- A11005002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861683108 EUDAMED
- Basic UDI-DI
- B-06973861683108 EUDAMED
- EMDN Code
- W0101060102 CHOLESTEROL TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
The TC Rapid Test Kit is a medical device designed for the rapid testing of microbial substances.
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-06973861683108 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Anbio (Xiamen) Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023936
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 204cb8f2-7de4-4d47-9648-f8556251a731 61 fields · synced Jul 25, 2026