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NC-15Plus(32)
EUDAMEDClass A (EU MDR)
Ref YETS0001EGModel nucleic acid extractor
Identity
- Device Name
- NC-15Plus(32) EUDAMED
- Model / Reference
- nucleic acid extractor EUDAMEDYETS0001EG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809886490026 EUDAMED
- Basic UDI-DI
- 880988649HWTPC-NC15PLUSL4 EUDAMED
- Direct Marketing DI
- 08809886490026 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
NC-15Plus(32) by HANWOOLTPC Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 880988649HWTPC-NC15PLUSL4 | Class A | Active |
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Manufacturer
- Manufacturer
- HANWOOLTPC Co., Ltd.
- EUDAMED SRN
- KR-MF-000026674
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED e685f98b-8db9-4091-b52b-08a59d89df86 61 fields · synced Jun 18, 2026