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Loopamp™ MTBC Detection Kit
EUDAMEDClass C (EU MDR)
Ref 972000Model Loopamp™ MTBC Detection Kit
Identity
- Trade Name
- Loopamp™ MTBC Detection Kit EUDAMED
- Model / Reference
- Loopamp™ MTBC Detection Kit EUDAMED972000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04033145191377 EUDAMED
- Basic UDI-DI
- 4987026TD-LFTBZE EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
Loopamp™ MTBC Detection Kit by Eiken Chemical Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4987026TD-LFTBZE | Class C | Active |
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Manufacturer
- Manufacturer
- Eiken Chemical Co., Ltd.
- EUDAMED SRN
- JP-MF-000018097
- Authorised Representative
- Human Gesellschaft für Biochemica und Diagnostica mbH DE-AR-000025586
Sources (1)
- EUDAMED 41a23d86-4d65-43cb-bc3b-10f5e5a7fba3 61 fields · synced Jul 16, 2026