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9799140106
EUDAMEDClass A (EU MDR)
Ref 9799140106Model Media:DirectTM Extraction Buffer
Identity
- Model / Reference
- Media:DirectTM Extraction Buffer EUDAMED9799140106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800118520511 EUDAMED
- Basic UDI-DI
- 88001185HR0020513L EUDAMED
- Direct Marketing DI
- 08800118520511 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
- Austria 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
Category: Nucleic acid extraction/isolation kit IVD
9799140106 by Genesystem Co., Ltd. — Class A — 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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88001185HR0020513L | Class A | Active |
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Manufacturer
- Manufacturer
- Genesystem Co., Ltd.
- EUDAMED SRN
- KR-MF-000022998
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 1241af1b-72d2-4253-b97a-ab52c4b30af4 61 fields · synced Jul 16, 2026