Identity
- Trade Name
- Magnetic Bead Nucleic Acid Extraction Kit EUDAMED
- Device Name
- Magnetic Bead Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- NAEM-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974900602019 EUDAMED
- Basic UDI-DI
- 697490060NAEM-01LD EUDAMED
- Direct Marketing DI
- 16974900602019 EUDAMED
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Magnetic Bead Nucleic Acid Extraction Kit by Zhuhai Shineway Biotech Co., Ltd — Class A — 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 | 697490060NAEM-01LD | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai Shineway Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000027278
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e9deea6c-ff9b-4bc2-887a-a2f04e215bd7 61 fields · synced Jul 12, 2026