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Procalcitonin(PCT) Assay Kit(Chemiluminescence)
EUDAMEDClass IVD General (EU MDR)
Ref DC0209Model 2×50 test/box Calibrator:0.5mL×6
Identity
- Trade Name
- Procalcitonin(PCT) Assay Kit(Chemiluminescence) EUDAMED
- Device Name
- Procalcitonin(PCT) Assay Kit(Chemiluminescence) EUDAMED
- Model / Reference
- 2×50 test/box Calibrator:0.5mL×6 EUDAMEDDC0209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970522644652 EUDAMED
- Basic UDI-DI
- B-06970522644652 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Procalcitonin(PCT) Assay Kit(Chemiluminescence) by Sichuan Orienter Biotechnology 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-06970522644652 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED dadf338e-2b85-48e2-8eda-a1907ba0680e 61 fields · synced Jun 19, 2026