Identity
- Trade Name
- iFlash-AMH EUDAMED
- Device Name
- iFlash-AMH EUDAMED
- Model / Reference
- C86316 EUDAMEDC86002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912723011 EUDAMED06925912718444 EUDAMED
- Basic UDI-DI
- 692591270010GL EUDAMED
- EMDN Code
- W0102050215 ANTI-MULLERIAN HORMONE 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-AMH 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 | 692591270010GL | Class B | 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 (2)
- EUDAMED 1f02155b-2245-4802-8a23-ac9ab72276d1 61 fields · synced Jul 15, 2026
- EUDAMED ce919590-9e18-4497-968d-ce114d767796 61 fields · synced May 18, 2026