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9799140107
EUDAMEDClass A (EU MDR)
Ref 9799140107Model Swab:DirectTM Extraction Kit, Swab:DirectTM Extraction Kit (2mL) / Trans:DirectTM Extraction Kit
Identity
- Model / Reference
- Swab:DirectTM Extraction Kit, Swab:DirectTM Extraction Kit (2mL) / Trans:DirectTM Extraction Kit EUDAMED9799140107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800118520436 EUDAMED
- Basic UDI-DI
- 88001185HR0020413H EUDAMED
- Direct Marketing DI
- 08800118520436 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
- Poland 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
9799140107 by Genesystem 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 | 88001185HR0020413H | 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 629b92d1-8c17-4344-b470-c04d944cb8da 61 fields · synced Jul 17, 2026