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TheraCHECK Dip Drug Test
EUDAMEDClass IVD General (EU MDR)
Ref 30170C-FRARef 30523-FRA
Identity
- Trade Name
- TheraCHECK Dip Drug Test EUDAMED
- Device Name
- TheraCHECK Single Dip Cassette Drug Test - BZO EUDAMEDTheraCHECK DIP DRUG TEST - AMP BZO COC OPI300 THC EUDAMED
- Model / Reference
- 30170C-FRA EUDAMED30523-FRA EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-30170C-FRAAK EUDAMEDD-30523-FRAQ5 EUDAMED
- Basic UDI-DI
- B-30170C-FRAAK EUDAMEDB-30523-FRAQ5 EUDAMED
- EMDN Code
- W0102090104 BENZODIAZEPINES EUDAMEDW0102090101,W0102090104,W0102090105,W0102090106,W0102090113 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
TheraCHECK Dip Drug Test by CareHealth America Corporation — 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-30170C-FRAAK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CareHealth America Corporation
- EUDAMED SRN
- US-MF-000025798
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 8cf15734-9c41-439d-a959-e7a712b834a5 61 fields · synced Oct 6, 2026
- EUDAMED ba6e1d74-23a8-4f6d-afbb-77a1eb51f29a 61 fields · synced May 17, 2026