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Hi-Swab DNA Kit
EUDAMEDClass A (EU MDR)
Ref CDP362-01Model CDP362-01, CDP362-02Ref CDP362-02
Identity
- Trade Name
- Hi-Swab DNA Kit EUDAMED
- Device Name
- Hi-Swab DNA Kit EUDAMED
- Model / Reference
- CDP362-01, CDP362-02 EUDAMEDCDP362-01 EUDAMEDCDP362-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489971100 EUDAMED06975489971117 EUDAMED
- Basic UDI-DI
- 697548997CDP362TX EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Hi-Swab DNA Kit by Tiangen Biotech (Beijing) 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 | 697548997CDP362TX | Class A | Active |
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Manufacturer
- Manufacturer
- Tiangen Biotech (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026594
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED e50259cb-ad25-4f67-ad5f-f108b05bb0f0 61 fields · synced Jul 11, 2026
- EUDAMED 79a6eaa3-4c00-4e48-a028-0ffe3b15d6db 61 fields · synced May 17, 2026