NC-15Plus(32)
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- Nucleic Acid Extractor FDA UDI
- Generic Name
- Magnetic particle separation instrument IVD FDA UDI
- Device Name
- NC-15Plus(32) EUDAMED
- Model / Reference
- nucleic acid extractor EUDAMEDHWTD-01-48 EUDAMEDNC-15PLUS(48) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809886490019 EUDAMEDFDA UDI
- Basic UDI-DI
- 880988649HWTPC-NC15PLUSL4 EUDAMED
- Direct Marketing DI
- 08809886490019 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Magnetic particle separation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Nucleic acid sample preparation instrument IVD
NC-15Plus(32) by HANWOOLTPC Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 880988649HWTPC-NC15PLUSL4 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- HANWOOLTPC Co., Ltd.
- EUDAMED SRN
- KR-MF-000026674
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (2)
- EUDAMED ce69375b-12d5-4af2-89a0-5613e47ad0f7 61 fields · synced Jul 17, 2026
- FDA UDI 74737875-f14f-4430-bc6f-98c4e86b4617 33 fields · synced May 29, 2026