Identity
- Trade Name
- iFlash-FSH EUDAMED
- Device Name
- iFlash-FSH EUDAMED
- Model / Reference
- C86011-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912715368 EUDAMED
- Basic UDI-DI
- 692591270012GQ EUDAMED
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class B 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
The iFlash-FSH device is a cutting-edge medical technology that utilizes innovative flash-based testing to provide accurate and reliable results in various clinical settings. With its compact design, ease of use, and high accuracy, it has gained popularity among healthcare professionals and researchers alike.
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 | 692591270012GQ | 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 c0b5a3db-fa8e-469f-9660-cd869ab4c304 61 fields · synced Jul 23, 2026