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Better2Know
EUDAMEDClass A (EU MDR)
Ref BHT0026Model Specimen ReceptaclesRef BHT0027Ref BHTK0025Ref BHTK0022Ref BHTK0024
by Better2Know
Identity
- Trade Name
- Better2Know EUDAMED
- Device Name
- DNA, Blood and Urine Collection Kits EUDAMED
- Model / Reference
- Specimen Receptacles EUDAMEDBHT0026 EUDAMEDBHT0027 EUDAMEDBHTK0025 EUDAMEDBHTK0022 EUDAMEDBHTK0024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060941800539 EUDAMED05060941800515 EUDAMED05060941800508 EUDAMED05060941800553 EUDAMED05060941800546 EUDAMED
- Basic UDI-DI
- 506094180BHTK86 EUDAMED
- EMDN Code
- W050101010102 BLOOD COLLECTION, CLOSED SYRINGES WITHOUT ADDITIVES EUDAMEDW05010202 URINE COLLECTION, TUBES EUDAMEDW0503010280 SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Better2Know by Better2Know — 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 | 506094180BHTK86 | Class A | Active |
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Manufacturer
- Manufacturer
- Better2Know
- EUDAMED SRN
- UK-MF-000044952
- Authorised Representative
- Patient Guard Europe UG DE-AR-000007523
Sources (5)
- EUDAMED ea3f64a9-1c62-4908-abca-b7d6e120360c 61 fields · synced Aug 1, 2026
- EUDAMED ff64cb79-e99d-4d0c-8999-7f922e898808 61 fields · synced May 17, 2026
- EUDAMED a33a17b9-07ff-4a2e-8b2b-55698069203a 61 fields · synced May 17, 2026
- EUDAMED ab44e15e-084f-4347-b019-2e91d7fbc688 61 fields · synced May 18, 2026
- EUDAMED 7893a091-395d-458f-950a-59ff6672d738 61 fields · synced May 18, 2026