Identity
- Trade Name
- iFlash-17α-OH-P EUDAMEDFDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-17α-OH-P EUDAMED
- Model / Reference
- C86061 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912718048 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270154HD EUDAMED
- FDA Product Code
- JLX FDA UDI
- EMDN Code
- W0102050107 17 OH PROGESTERONE EUDAMED
- GMDN Term
- 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1395 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
iFlash-17α-OH-P by Shenzhen Yhlo Biotech Co., Ltd. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 692591270154HD | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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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 501283d3-c94f-49d0-b751-14931d46aecc 61 fields · synced Aug 1, 2026
- FDA UDI ec7a4813-a455-4575-b5ab-39a2a213a10b 32 fields · synced May 30, 2026