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HighPrep PCR - DX (1000 mL)
EUDAMEDClass A (EU MDR)
Ref AC-61000EModel Device for post-PCR and post-enzymatic reaction clean-up
Identity
- Trade Name
- HighPrep PCR - DX (1000 mL) EUDAMED
- Device Name
- HighPrep PCR - DX (1000 mL) EUDAMED
- Model / Reference
- Device for post-PCR and post-enzymatic reaction clean-up EUDAMEDAC-61000E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850049735629 EUDAMED
- Basic UDI-DI
- 0850049735AC-61000ET6 EUDAMED
- Direct Marketing DI
- 00850049735629 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
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
HighPrep PCR - DX (1000 mL) by MagBio Genomics, Inc. — 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 | 0850049735AC-61000ET6 | Class A | Active |
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Manufacturer
- Manufacturer
- MagBio Genomics, Inc.
- EUDAMED SRN
- US-MF-000038221
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 700c1378-17d2-4f69-b2bc-753b0be9ca20 61 fields · synced Jul 11, 2026