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Transport Mediums
EUDAMEDClass A (EU MDR)
Ref MT-DTM001 Model "MT-DTM001,MT-DTM002; MT-HTM001,MT-HTM002; MT-IVT001,MT-IVT002,MT-SVT001,MT-SVT002; MT-CTM001; MT-LAT001,MT-LAT002; MT-FTM001,MT-FTM002,MT-FTM003;"
Identity
- Device Name
- Transport Mediums EUDAMED
- Model / Reference
- "MT-DTM001,MT-DTM002; MT-HTM001,MT-HTM002; MT-IVT001,MT-IVT002,MT-SVT001,MT-SVT002; MT-CTM001; MT-LAT001,MT-LAT002; MT-FTM001,MT-FTM002,MT-FTM003;" EUDAMEDMT-DTM001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974760785016 EUDAMED
- Basic UDI-DI
- 697476078MediumsAS 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
Transport Mediums 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 | 697476078MediumsAS | 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 41375241-c0fa-41c6-ba68-fbcbc0636536 61 fields · synced Jul 10, 2026