Identity
- Trade Name
- ACCU-ANSWER EUDAMED
- Device Name
- Total Cholesterol Test Strips EUDAMED
- Model / Reference
- TC01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697191378-TCTSHS EUDAMED
- Basic UDI-DI
- B-697191378-TCTSHS EUDAMED
- EMDN Code
- W0101060102 CHOLESTEROL TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Accu-Answer by Guilin Royalyze Medical Instrument Co., Ltd. — Class IVD devices for self-testing — 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-697191378-TCTSHS | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Guilin Royalyze Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000038422
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED aa39f27b-48c0-4f38-8e1e-6773c657ab37 61 fields · synced Jul 23, 2026