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Better2Know
EUDAMEDClass A (EU MDR)
Ref BHTK0021Model Specimen Receptacles
by Better2Know
Identity
- Trade Name
- Better2Know EUDAMED
- Device Name
- DNA, Blood and Urine Collection Kits EUDAMED
- Model / Reference
- Specimen Receptacles EUDAMEDBHTK0021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060941800522 EUDAMED
- Basic UDI-DI
- 506094180BHTK86 EUDAMED
- EMDN Code
- W050101010102 BLOOD COLLECTION, CLOSED SYRINGES WITHOUT ADDITIVES 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 (1)
- EUDAMED 595b5b28-8983-4b79-b5ec-9e00b49ea366 61 fields · synced Jun 19, 2026