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Nucleic Acid Extraction Reagent (Magnetic beads)
EUDAMEDClass A (EU MDR)
Ref N3002DRef N3001BRef N3002C
Identity
- Trade Name
- Nucleic Acid Extraction Reagent (Magnetic beads) EUDAMEDNucleic Acid Extraction Reagent EUDAMED
- Device Name
- Nucleic Acid Extraction Reagent (Magnetic beads) EUDAMEDNucleic Acid Extraction Reagent EUDAMED
- Model / Reference
- N3002D EUDAMEDN3001B EUDAMEDN3002C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996040211 EUDAMED06950996091565 EUDAMED06950996032537 EUDAMED
- Basic UDI-DI
- 69509960N3002DEE EUDAMED69509960N3001BE7 EUDAMED69509960N3002CEC EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER 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
Nucleic Acid Extraction Reagent (Magnetic beads) by Zhejiang Orient Gene 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 | 69509960N3002DEE | Class A | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 78b60e7a-8562-4e15-897a-6bdf7ff4ddae 61 fields · synced Oct 6, 2026
- EUDAMED adf74f79-3991-4716-a4c7-76187a3b75bb 61 fields · synced May 17, 2026
- EUDAMED acc30966-4bf8-4175-9951-6304d0e4afc5 61 fields · synced May 19, 2026