Identity
- Trade Name
- iFlash-AFP EUDAMED
- Device Name
- iFlash-AFP EUDAMED
- Model / Reference
- C86003-S EUDAMEDC86003 EUDAMEDC86003-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912723103 EUDAMED06925912718536 EUDAMED06925912711728 EUDAMED
- Basic UDI-DI
- 692591270022GT EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
iFlash-AFP by Shenzhen Yhlo Biotech Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 692591270022GT | Class C | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED a0563003-ed54-4d47-b6f7-3e7f886f75e8 61 fields · synced Jul 24, 2026
- EUDAMED 8be7e95f-8627-4779-8763-c2b523879c5d 61 fields · synced May 18, 2026
- EUDAMED 4b5b53a4-b74c-4f21-9ff4-1f302aa82a72 61 fields · synced May 19, 2026