Identity
- Trade Name
- TRUPCR® BS DNA Extraction Kit EUDAMED
- Device Name
- TRUPCR® BS DNA Extraction Kit EUDAMED
- Model / Reference
- 3B215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061021472240 EUDAMEDD-5061021472240NZ EUDAMED
- Basic UDI-DI
- 5061021473B215FN EUDAMEDB-5061021472240NZ EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Northern Ireland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
TRUPCR® BS DNA Extraction Kit by 3B BlackBio Dx Limited — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 5061021473B215FN | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 5061021473B215FN | Class A | Active |
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Manufacturer
- Manufacturer
- 3B BlackBio Dx Limited
- EUDAMED SRN
- IN-MF-000023698
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED fddb287e-39f9-4c45-8603-1dd2673dd717 61 fields · synced Jul 9, 2026
- EUDAMED 81525bdd-98ae-4337-a860-6631037d9ebc 61 fields · synced May 19, 2026