Identity
- Device Name
- Viral DNA/RNA Isolation Kit EUDAMED
- Model / Reference
- 06 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974573530114 EUDAMED
- Basic UDI-DI
- 6974573530000016Q7 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER 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
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Viral DNA/RNA Isolation Kit by Suzhou CellPro Biotechnology 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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- 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 | 6974573530000016Q7 | Class A | Active |
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Manufacturer
- Manufacturer
- Suzhou CellPro Biotechnology Co., LTD.
- EUDAMED SRN
- CN-MF-000008875
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 1ec8a72d-5914-4866-a09d-8b5b5b9dd95f 61 fields · synced Jul 10, 2026