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Uni-medica
EUDAMEDClass A (EU MDR)
Ref /Model VST-01, VST-02, VST-03 3mL×20Pcs, 3mL× 50Pcs, 3mL×100PcsRef 16.03.001.01Model TypeB 100 tests/kitModel 64T, 96T, 384T, 100T, 300T, 1000T, 4800TRef 15.09.002.02Model NFAST 96, NFAST 32A
Identity
- Trade Name
- Uni-medica EUDAMED
- Device Name
- Disposable Virus Sampling Tube EUDAMEDSample release reagent EUDAMEDNucleic Acid Extraction Reagent EUDAMEDNucleic Acid Extractor EUDAMED
- Model / Reference
- VST-01, VST-02, VST-03 3mL×20Pcs, 3mL× 50Pcs, 3mL×100Pcs EUDAMED/ EUDAMEDTypeB 100 tests/kit EUDAMED16.03.001.01 EUDAMED64T, 96T, 384T, 100T, 300T, 1000T, 4800T EUDAMEDNFAST 96, NFAST 32A EUDAMED15.09.002.02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974561521271 EUDAMED06974561520144 EUDAMED06974561521295 EUDAMED06974561521226 EUDAMED06974561521288 EUDAMED06974561521233 EUDAMED06974561520069 EUDAMED06974561520083 EUDAMED06974561520076 EUDAMED06974561520113 EUDAMED
- Basic UDI-DI
- 697456152VST-01TC EUDAMED697456152100tests/kit3M EUDAMED69745615264TPF EUDAMED697456152NFAST32ABE EUDAMED
- Direct Marketing DI
- 06974561521271 EUDAMED06974561520144 EUDAMED06974561521295 EUDAMED06974561521226 EUDAMED06974561521288 EUDAMED06974561521233 EUDAMED06974561520069 EUDAMED06974561520083 EUDAMED06974561520076 EUDAMED06974561520113 EUDAMED
- EMDN Code
- W05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMEDW0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMEDW02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
New Device
No
EUDAMED
Uni-medica by Shenzhen Uni-medica Technology 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 | 697456152VST-01TC | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Uni-medica Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022946
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (10)
- EUDAMED 6a3930f3-aedd-47ce-847d-039b7f8a0817 61 fields · synced Jul 30, 2026
- EUDAMED 9da09269-9767-4e6c-91a8-68b95770a94d 61 fields · synced May 11, 2026
- EUDAMED bbf2a42c-366c-4583-9427-3fbcded7950d 61 fields · synced May 16, 2026
- EUDAMED 5245185a-f3bd-46f2-9c9f-60612ff69054 61 fields · synced May 16, 2026
- EUDAMED aa553df9-d927-45e2-a3dd-1d5600983c1a 61 fields · synced May 18, 2026
- EUDAMED 5871c5b9-3309-4c3a-b810-ca330f1d257c 61 fields · synced May 18, 2026
- EUDAMED 6f68f580-18fc-43cb-b5c4-4f71a6a522ac 61 fields · synced May 18, 2026
- EUDAMED a6aa4680-2cb0-444c-930d-389cbd0bacdb 61 fields · synced May 19, 2026
- EUDAMED e75a1b94-7a73-4202-9458-8eff9def5929 61 fields · synced May 19, 2026
- EUDAMED d9333cee-e357-47b6-a63b-b85cea687017 61 fields · synced May 19, 2026