Identity
- Trade Name
- Immunoassay Multi Control EUDAMED
- Device Name
- Immunoassay Multi Control EUDAMED
- Model / Reference
- CC817 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CC817RB EUDAMED06925912738947 EUDAMED
- Basic UDI-DI
- B-CC817RB EUDAMED692591270139HH EUDAMED
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMEDW0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Greece EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
New Device
No
EUDAMED
Immunoassay 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-CC817RB | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-CC817RB | 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 bb075624-e64a-4112-91ba-6b3562525c0b 61 fields · synced Aug 3, 2026
- EUDAMED 7263abda-9b8f-4d42-91db-7b1608ce745d 61 fields · synced Aug 3, 2026