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Marijuana Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref THC-U11 THC-U23Model THC-U11, THC-U23Ref THC-U23,THC-U11
Identity
- Trade Name
- Marijuana Rapid Test EUDAMED
- Device Name
- Marijuana Rapid Test EUDAMED
- Model / Reference
- THC-U11, THC-U23 EUDAMEDTHC-U11 THC-U23 EUDAMEDTHC-U23,THC-U11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804814410 EUDAMED06952804814397 EUDAMED
- Basic UDI-DI
- B-06952804814410 EUDAMEDB-06952804814397 EUDAMED
- EMDN Code
- W0102160505 CANNABINOIDS - RT & POC EUDAMEDW0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER 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
Marijuana Rapid Test by Assure Tech. (hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06952804814410 | 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 (3)
- EUDAMED dc70d98b-4816-48d3-b0d2-5d1be6989d16 61 fields · synced Jul 25, 2026
- EUDAMED fc155cb3-28ec-48e7-88b9-fe272c627a3a-1 61 fields · synced Jul 25, 2026
- EUDAMED fc155cb3-28ec-48e7-88b9-fe272c627a3a-2 61 fields · synced Jul 25, 2026