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Pathogen Nucleic Acid Extraction Kit
EUDAMEDClass A (EU MDR)
Ref KS148-BYTQ-D96Model Type A: 100 tests/kit Type B: 24 tests/kit Type B: 48 tests/kit Type B: 96 tests/kit Type C: 96 tests/kit Type D: 6×16 tests/kitRef KS148-BYTQ-B48Ref KS148-BYTQ-B96Ref KS148-BYTQ-C96
Identity
- Device Name
- Pathogen Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- Type A: 100 tests/kit Type B: 24 tests/kit Type B: 48 tests/kit Type B: 96 tests/kit Type C: 96 tests/kit Type D: 6×16 tests/kit EUDAMEDKS148-BYTQ-D96 EUDAMEDKS148-BYTQ-B48 EUDAMEDKS148-BYTQ-B96 EUDAMEDKS148-BYTQ-C96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974987421476 EUDAMED06974987421445 EUDAMED06974987421452 EUDAMED06974987421469 EUDAMED
- Basic UDI-DI
- 697498742KS1480014Y EUDAMED
- Direct Marketing DI
- 06974987421476 EUDAMED06974987421445 EUDAMED06974987421452 EUDAMED06974987421469 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
- 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
Category: Nucleic acid extraction/isolation kit IVD
Pathogen Nucleic Acid Extraction Kit by Guangzhou KingCreate Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
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 | 697498742KS1480014Y | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou KingCreate Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032033
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (4)
- EUDAMED 6cb74395-1c7f-4800-9074-9393f3494019 61 fields · synced Jul 30, 2026
- EUDAMED 5f0da37e-6208-407d-b586-88ed5aece133 61 fields · synced May 17, 2026
- EUDAMED 8a05d8c7-2dfd-44dc-8c57-1761aaa87b9f 61 fields · synced May 17, 2026
- EUDAMED 3f836a81-029d-4b19-8812-c3255eef6e1c 61 fields · synced May 17, 2026