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DNA/RNA Extraction/Purification Kit
EUDAMEDClass A (EU MDR)
Ref BFMP08RFModel 1T、32T、96T、100T、256TRef BFMP08RRef BFMP08R16Ref BFMP10R96Ref BFMP12R96Ref BFMP02MRef BFMP08R1Ref BFMP04R96Ref BFMP15R1Ref BFMP02R96Ref BFMP04MRef BFMP15RRef BFMP14RRef BFMP25LRef BFMP08LRef BFMP04R1Ref BFMP12RRef BFMP25R1Ref BFMP14R1Ref BFMP11R24Ref BFMP08MRef BFMP06MRef BFMP02RRef BFMP08R96Ref BFMP05R96Ref BFMP12R1Ref BFMP05R1
Identity
- Device Name
- DNA/RNA Extraction/Purification Kit EUDAMED
- Model / Reference
- 1T、32T、96T、100T、256T EUDAMEDBFMP08RF EUDAMEDBFMP08R EUDAMEDBFMP08R16 EUDAMEDBFMP10R96 EUDAMEDBFMP12R96 EUDAMEDBFMP02M EUDAMEDBFMP08R1 EUDAMEDBFMP04R96 EUDAMEDBFMP15R1 EUDAMEDBFMP02R96 EUDAMEDBFMP04M EUDAMEDBFMP15R EUDAMEDBFMP14R EUDAMEDBFMP25L EUDAMEDBFMP08L EUDAMEDBFMP04R1 EUDAMEDBFMP12R EUDAMEDBFMP25R1 EUDAMEDBFMP14R1 EUDAMEDBFMP11R24 EUDAMEDBFMP08M EUDAMEDBFMP06M EUDAMEDBFMP02R EUDAMEDBFMP08R96 EUDAMEDBFMP05R96 EUDAMEDBFMP12R1 EUDAMEDBFMP05R1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975514360251 EUDAMED06975514360244 EUDAMED06975514360787 EUDAMED06975514360664 EUDAMED06975514360671 EUDAMED06975514360329 EUDAMED06975514360183 EUDAMED06975514360633 EUDAMED06975514360763 EUDAMED06975514360626 EUDAMED06975514360336 EUDAMED06975514360602 EUDAMED06975514360312 EUDAMED06975514360718 EUDAMED06975514360428 EUDAMED06975514360145 EUDAMED06975514360299 EUDAMED06975514360770 EUDAMED06975514360756 EUDAMED06975514360725 EUDAMED06975514360374 EUDAMED06975514360350 EUDAMED06975514360190 EUDAMED06975514360305 EUDAMED06975514360640 EUDAMED06975514360749 EUDAMED06975514360152 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 (27)
- EUDAMED a7f1d2ee-984a-4327-8994-fe9a1ef1a575 61 fields · synced Sep 17, 2026
- EUDAMED 43b742bc-7e29-4a98-9586-402ccee3a920 61 fields · synced May 16, 2026
- EUDAMED 6c033375-52f2-4387-8ee9-24ee81b9e508 61 fields · synced May 16, 2026
- EUDAMED 85a68f7a-580a-4a95-ad0a-aadd9b007f70 61 fields · synced May 17, 2026
- EUDAMED abfe607d-5329-4aba-9b55-6d5b70de6715 61 fields · synced May 17, 2026
- EUDAMED e9b6869e-9980-48bd-8678-5e742e09110e 61 fields · synced May 17, 2026
- EUDAMED f333a79a-087e-4272-96c9-0990f9e54afd 61 fields · synced May 17, 2026
- EUDAMED 4d91bb82-24db-4498-aa2b-d3d423866ba3 61 fields · synced May 17, 2026
- EUDAMED 30ad4e77-b544-4377-afcb-18da2473548f 61 fields · synced May 17, 2026
- EUDAMED 2f8e8507-e1c9-4803-ac55-f02b5ae4eccb 61 fields · synced May 17, 2026
- EUDAMED bb6c816e-2d8e-4e84-a2d5-6fbf730cb1f7 61 fields · synced May 17, 2026
- EUDAMED cb6549a4-ac0e-43ac-9a77-109308ed5248 61 fields · synced May 17, 2026
- EUDAMED 918954d7-20f3-43f2-9b19-5db896232bb5 61 fields · synced May 17, 2026
- EUDAMED 9a560453-38be-48e6-9585-b25691bb1a7f 61 fields · synced May 17, 2026
- EUDAMED 5f0ea85d-7265-405c-8ff9-e16d4fdbda09 61 fields · synced May 18, 2026
- EUDAMED 5de25fcf-72c7-4c92-b096-1f752d7af6e5 61 fields · synced May 18, 2026
- EUDAMED ff210bd9-05a4-4ba0-b1dc-47cd66878774 61 fields · synced May 18, 2026
- EUDAMED 9c07dce7-153c-4745-9785-b18d1b51f1fa 61 fields · synced May 18, 2026
- EUDAMED 103aa7a3-97b7-4b28-9af8-514ef296d339 61 fields · synced May 18, 2026
- EUDAMED 2f670ffc-24e1-4786-8002-44ece3ee98f9 61 fields · synced May 18, 2026
- EUDAMED 3181fc0b-72de-4946-a356-95235f283154 61 fields · synced May 18, 2026
- EUDAMED 7d16927a-62b9-4562-b374-2a5a2bfa5348 61 fields · synced May 18, 2026
- EUDAMED 002a9ba9-1ccf-42a7-9c05-8934c98b33ba 61 fields · synced May 18, 2026
- EUDAMED a3a245db-389b-4e68-b3a7-b8b8150212ec 61 fields · synced May 19, 2026
- EUDAMED bc0d8c51-2fd6-4cf7-8a7e-1b0503a5b3c9 61 fields · synced May 19, 2026
- EUDAMED decb93b2-463a-4e5a-8858-a80750bb094c 61 fields · synced May 19, 2026
- EUDAMED 41a00377-0787-4fc3-b815-e9bcdff17fb6 61 fields · synced May 19, 2026