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Nucleic Acid Extraction Reagent
EUDAMEDClass A (EU MDR)
Ref 48 tests/kit, 96 tests/kit, 32 tests/kit (pre-packaged), 96 tests/kit (pre-packaged)Model 48 tests/kit, 96 tests/kit, 32 tests/kit (pre-packaged), 96 tests/kit (pre-packaged)
Identity
- Device Name
- Nucleic Acid Extraction Reagent EUDAMED
- Model / Reference
- 48 tests/kit, 96 tests/kit, 32 tests/kit (pre-packaged), 96 tests/kit (pre-packaged) EUDAMED48 tests/kit, 96 tests/kit, 32 tests/kit (pre-packaged), 96 tests/kit (pre-packaged) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972221450657 EUDAMED
- Basic UDI-DI
- 697222145067FW 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 Extraction Reagent by CapitalBio Technology (Chengdu) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 697222145067FW | Class A | Active |
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Manufacturer
- Manufacturer
- CapitalBio Technology (Chengdu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000027694
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 71b8838b-9e19-4c9b-b1b2-50df0861fcad 61 fields · synced Jun 17, 2026
- EUDAMED 71b8838b-9e19-4c9b-b1b2-50df0861fcad-1 61 fields · synced Jun 9, 2026