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HPV Genotyping Kit (18 Types)
EUDAMEDClass C (EU MDR)
Ref KS305-HPV48Model 48 Tests/KitRef KS624-HPVB24Model Specification B: 8 tests/strip, 24 tests/boxRef KS624-HPVA24Model Specification A: 1 test/tube, 24 tests/box
Identity
- Trade Name
- HPV Genotyping Kit (18 Types) EUDAMEDHPV Genotyping Kit EUDAMED
- Device Name
- HPV Genotyping Kit (18 Types) EUDAMEDHPV Genotyping Kit EUDAMED
- Model / Reference
- 48 Tests/Kit EUDAMEDKS305-HPV48 EUDAMEDSpecification B: 8 tests/strip, 24 tests/box EUDAMEDKS624-HPVB24 EUDAMEDSpecification A: 1 test/tube, 24 tests/box EUDAMEDKS624-HPVA24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974987420110 EUDAMED06974987420066 EUDAMED06974987420059 EUDAMED
- Basic UDI-DI
- 697498742KS3050013R EUDAMEDB-06974987420066 EUDAMEDB-06974987420059 EUDAMED
- Direct Marketing DI
- 06974987420110 EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
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
HPV Genotyping Kit (18 Types) by Guangzhou KingCreate Biotechnology Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697498742KS3050013R | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 697498742KS3050013R | Class C | 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 (3)
- EUDAMED 307b0930-0862-4106-a4ff-39bf10fff1f6 61 fields · synced Sep 17, 2026
- EUDAMED 43133746-55d5-4b79-9ce0-11e38537fd80 61 fields · synced May 18, 2026
- EUDAMED 7ae7a185-f743-4693-aa35-9b8dbe2a30db 61 fields · synced May 18, 2026