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bigfish
EUDAMEDClass A (EU MDR)
Ref N/A Model BFQP-48、BFQP-96Ref N/AModel BFEX-16、BFEX-32、BFEX-96、BFEX-96EModel 1T、32T、96T、100T、256TModel BFDS-NA01、BFDS-NA02Model BFVTM-50B、BFVTM-50D
Identity
- Trade Name
- bigfish EUDAMED
- Device Name
- Real-time Fluorescent Quantitative PCR Analyzer EUDAMEDAutomatic Nucleic Acid Purification Instrument EUDAMEDDNA/RNA Extraction/Purification Kit EUDAMEDDisposable Sampling Swabs EUDAMEDViral Transport Medium Kit EUDAMED
- Model / Reference
- BFQP-48、BFQP-96 EUDAMEDN/A EUDAMEDBFEX-16、BFEX-32、BFEX-96、BFEX-96E EUDAMED1T、32T、96T、100T、256T EUDAMEDBFDS-NA01、BFDS-NA02 EUDAMEDBFVTM-50B、BFVTM-50D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975514360060 EUDAMED06975514360091 EUDAMED06975514360039 EUDAMED06975514360084 EUDAMED26975514360132 EUDAMED16975514360524 EUDAMED06975514360022 EUDAMED16975514360456 EUDAMED06975514360015 EUDAMED06975514360121 EUDAMED06975514360046 EUDAMED
- Basic UDI-DI
- 697551436BFQP001PX EUDAMED697551436BFEX001MK EUDAMED697551436BFMP001NK EUDAMED697551436BFNA001KM EUDAMED697551436BFVTM0029M EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMEDW02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMEDW01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMEDA1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMEDW05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
bigfish by Hangzhou Bigfish Bio-tech Co., Ltd. — Class A — MDR, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697551436BFQP001PX | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 697551436BFQP001PX | 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 (11)
- EUDAMED edde746b-de20-421f-83a1-851d1cffea0b 61 fields · synced Aug 1, 2026
- EUDAMED ae7d07b2-79ff-49f8-acd7-426efd0ab22f 61 fields · synced May 16, 2026
- EUDAMED 6e3582bd-0022-4222-b035-0189c7d92cda 61 fields · synced May 17, 2026
- EUDAMED 58d07df1-909c-4cf7-96a6-065d47f6dd84 61 fields · synced May 17, 2026
- EUDAMED 5d3f4637-944d-4acc-8ab9-94d8e356b88c 61 fields · synced May 18, 2026
- EUDAMED 00185ddf-9dfc-41f3-a84c-269eadfc5dba 61 fields · synced May 18, 2026
- EUDAMED 067016c5-1bad-46e1-ac6f-817d11ad2efe 61 fields · synced May 19, 2026
- EUDAMED b1310922-2f6a-44bf-9bb5-dff570755b2f 61 fields · synced May 19, 2026
- EUDAMED cf032c86-9e7f-49bd-b57c-4d91ffaa20e3 61 fields · synced May 19, 2026
- EUDAMED 9716b4b9-6ce1-4d6d-8d9b-582d77c82c22 61 fields · synced May 19, 2026
- EUDAMED f000355b-8e64-4ffa-bd43-f4763b0bbf82 61 fields · synced May 19, 2026