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Nucleic Acid Exctraction/Purification Kit
EUDAMEDClass A (EU MDR)
Ref 96tests/kitModel 96tests/kit, 120tests/kit, 144tests/kit, 160tests/kit, 480tests/kit
Identity
- Device Name
- Nucleic Acid Exctraction/Purification Kit EUDAMED
- Model / Reference
- 96tests/kit, 120tests/kit, 144tests/kit, 160tests/kit, 480tests/kit EUDAMED96tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974776970017 EUDAMED
- Basic UDI-DI
- 697477697NAEPK019V EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Nucleic Acid Exctraction/Purification Kit by CapitalBio Genomics 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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- 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 | 697477697NAEPK019V | Class A | Active |
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Manufacturer
- Manufacturer
- CapitalBio Genomics Co., Ltd.
- EUDAMED SRN
- CN-MF-000027716
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 28481383-f62b-4e55-8583-513b8ca0f74a 61 fields · synced Jun 18, 2026