Identity
- Trade Name
- iFlash-SMA IgG EUDAMED
- Device Name
- iFlash-SMA IgG EUDAMED
- Model / Reference
- C88046G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912720256 EUDAMED
- Basic UDI-DI
- 692591270075HG EUDAMED
- EMDN Code
- W0102100799 AUTOIMMUNE HEPATITIS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
iFlash-SMA IgG by Shenzhen Yhlo Biotech Co., Ltd. — Class B — 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 | 692591270075HG | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 10b92bd2-70a1-4df7-8782-7483fd5c9771 61 fields · synced Jul 13, 2026