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Ecstasy Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref MDMA-U11, MDMA-U23Ref MDMA-W23, MDMA-U11Model Device
Identity
- Trade Name
- Ecstasy Rapid Test EUDAMED
- Device Name
- Ecstasy Rapid Test EUDAMEDMDMA Rapid Test EUDAMED
- Model / Reference
- MDMA-U11, MDMA-U23 EUDAMEDDevice EUDAMEDMDMA-W23, MDMA-U11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804816926 EUDAMED06952804811532 EUDAMED
- Basic UDI-DI
- B-06952804816926 EUDAMEDB-06952804811532 EUDAMED
- EMDN Code
- W0102160502 AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - 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
Ecstasy 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-06952804816926 | 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 (4)
- EUDAMED 135a79f4-b8f8-4e83-8b8b-f7d5df06acba 61 fields · synced Jul 25, 2026
- EUDAMED 135a79f4-b8f8-4e83-8b8b-f7d5df06acba-1 61 fields · synced Jun 10, 2026
- EUDAMED 2f73dd9e-a559-4171-97f9-d6f3b8734cd0-1 61 fields · synced Jul 25, 2026
- EUDAMED 2f73dd9e-a559-4171-97f9-d6f3b8734cd0-2 61 fields · synced Jul 25, 2026