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IntelliPrep cfDNA Extraction Kit (≦5 mL)
EUDAMEDClass A (EU MDR)
Ref 83013Model 83015
Identity
- Trade Name
- IntelliPrep cfDNA Extraction Kit (≦5 mL) EUDAMED
- Device Name
- IntelliPrep FFPE DNA Extraction Kit EUDAMED
- Model / Reference
- 83015 EUDAMED83013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719882810299 EUDAMED
- Basic UDI-DI
- 471988281ExtractionKitP6 EUDAMED
- Direct Marketing DI
- 04719882810299 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
IntelliPrep cfDNA Extraction Kit (≦5 mL) by PlexBio 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 | 471988281ExtractionKitP6 | Class A | Active |
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Manufacturer
- Manufacturer
- PlexBio Co., Ltd.
- EUDAMED SRN
- TW-MF-000031803
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 6d9b367b-7b33-4105-a117-7f217797cf28 61 fields · synced Jun 18, 2026