Identity
- Trade Name
- BasePurifier EUDAMED
- Device Name
- BasePurifier™ 32 Nucleic Acid Extraction System 32 Oscillating Rods EUDAMEDBasePurifier™ 96 Nucleic Acid Extraction System 96 Rotating Rods EUDAMEDBasePurifier™ 48 Large Volume Nucleic Acid Extraction System 48 Rotating Rods EUDAMED
- Model / Reference
- 715 EUDAMED719 EUDAMED718 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713915000533 EUDAMED05713915000526 EUDAMED05713915000519 EUDAMED
- Basic UDI-DI
- 5713915BP001NK EUDAMED5713915BP002NM EUDAMED5713915BP003NP EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark 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
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
BasePurifier by PentaBase A/S — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5713915BP001NK | Class A | Active |
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Manufacturer
- Manufacturer
- PentaBase A/S
- EUDAMED SRN
- DK-MF-000023157
Sources (3)
- EUDAMED a427294d-dc79-48ac-945a-d2a6a25143bb 61 fields · synced Jul 21, 2026
- EUDAMED 15493b75-552e-4e9c-b8e3-16ec30c7560b 61 fields · synced May 17, 2026
- EUDAMED e8ea1652-4f69-4379-8af6-7e5b892a6194 61 fields · synced May 18, 2026