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HCY Nucleic Acid Extraction & Purification Kit
EUDAMEDClass A (EU MDR)
Ref CY-M001-50Model CY-M002-50, CY-M002-100, CY-M002-200, CY-M002-96, CY-M001-96, CY-M001-50, CY-M001-100, CY-M001-200
Identity
- Trade Name
- HCY Nucleic Acid Extraction & Purification Kit EUDAMED
- Device Name
- HCY Nucleic Acid Extraction & Purification Kit EUDAMED
- Model / Reference
- CY-M002-50, CY-M002-100, CY-M002-200, CY-M002-96, CY-M001-96, CY-M001-50, CY-M001-100, CY-M001-200 EUDAMEDCY-M001-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974488992130 EUDAMED
- Basic UDI-DI
- 697448899CY-M0/0/8/2/8VFZ EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Category: Nucleic acid extraction/isolation kit IVD
HCY Nucleic Acid Extraction & Purification Kit by Huachenyang (Shenzhen) Technology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 697448899CY-M0/0/8/2/8VFZ | Class A | Active |
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Manufacturer
- Manufacturer
- Huachenyang (Shenzhen) Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020236
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6b4068e1-e791-4d83-a89f-7891e37a6b96 61 fields · synced Jun 18, 2026