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DNA/RNA Extraction/Purification Kit
EUDAMEDClass A (EU MDR)
Ref BFMP05RModel 1T、32T、96T、100T、256T
Identity
- Device Name
- DNA/RNA Extraction/Purification Kit EUDAMED
- Model / Reference
- 1T、32T、96T、100T、256T EUDAMEDBFMP05R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975514360213 EUDAMED
- Basic UDI-DI
- 697551436BFMP001NK EUDAMED
- EMDN Code
- W0104080601 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
DNA/RNA Extraction/Purification Kit by Hangzhou Bigfish Bio-tech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697551436BFMP001NK | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bigfish Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000027212
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5e498100-46c1-4668-949f-174ae1b32cd8 61 fields · synced Jun 19, 2026