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Multi-drug Single-line Whole Blood Test Device
EUDAMEDClass IVD General (EU MDR)
Ref MD-W42~MD-W415
Identity
- Device Name
- Multi-drug Single-line Whole Blood Test Device EUDAMED
- Model / Reference
- MD-W42~MD-W415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MD-W42W415TT EUDAMED
- Basic UDI-DI
- B-MD-W42W415TT EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Multi-drug Single-line Whole Blood Test Device by Assure Tech. (hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-MD-W42W415TT | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 1caa5b52-3e7d-4301-9585-12b39dfdf20a 61 fields · synced Jun 19, 2026