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DNA Prep Kit
EUDAMEDClass A (EU MDR)
Ref HBDPModel 30 Tests/ Kit, 24 Tests/ Kit, 6 Tests/ Kit
Identity
- Device Name
- DNA Prep Kit EUDAMED
- Model / Reference
- 30 Tests/ Kit, 24 Tests/ Kit, 6 Tests/ Kit EUDAMEDHBDP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942221703343 EUDAMED
- Basic UDI-DI
- 69422217HBDPPJ 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
- Netherlands 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
DNA Prep Kit by Chaozhou Hybribio Biochemistry 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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- Pathogen DNA/RNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., 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 | 69422217HBDPPJ | Class A | Active |
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Manufacturer
- Manufacturer
- Chaozhou Hybribio Biochemistry Ltd.
- EUDAMED SRN
- CN-MF-000023818
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 3d30477d-f741-4118-a87e-c491b8240ecd 61 fields · synced Jul 10, 2026