Identity
- Trade Name
- Autoimmune Diabetes Multi Control EUDAMED
- Device Name
- Autoimmune Diabetes Multi Control EUDAMED
- Model / Reference
- CC829 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CC829RJ EUDAMED06925912738626 EUDAMED
- Basic UDI-DI
- B-CC829RJ EUDAMED692591270126H8 EUDAMED
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMEDW0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
New Device
No
EUDAMED
Autoimmune Diabetes Multi Control by Shenzhen Yhlo Biotech Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-CC829RJ | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-CC829RJ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED c3b9f998-65c5-4acf-a5b5-8e3e3b4b4186 61 fields · synced Jul 30, 2026
- EUDAMED 2a3eddac-bfe5-49d1-bf7b-8bd24c071f44 61 fields · synced Jul 30, 2026