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Disposable Sampling Kits
EUDAMEDClass A (EU MDR)
Ref MSK-HSK001Model MSK-HSK001,MSK-HSK002, MSK-HSK003,MSK-HSK004,MSK-HSK005,MSK-HSK006
Identity
- Device Name
- Disposable Sampling Kits EUDAMED
- Model / Reference
- MSK-HSK001,MSK-HSK002, MSK-HSK003,MSK-HSK004,MSK-HSK005,MSK-HSK006 EUDAMEDMSK-HSK001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974760786068 EUDAMED
- Basic UDI-DI
- 697476078HPVSAMPLINGKITDY EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER 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
No
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
Disposable Sampling Kits by Shenzhen Mandelab 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 | 697476078HPVSAMPLINGKITDY | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen MandeLab Co., Ltd.
- EUDAMED SRN
- CN-MF-000009021
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED aa33d8c3-4d16-483e-be94-4069fc54e4ed 61 fields · synced Jun 19, 2026