Identity
- Trade Name
- iFlash-hGH EUDAMEDFDA UDI
- Generic Name
- Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-hGH EUDAMED
- Model / Reference
- C86053 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912719281 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270165HJ EUDAMED
- FDA Product Code
- CFL FDA UDI
- EMDN Code
- W0102060402 HUMAN GROWTH HORMONE EUDAMED
- GMDN Term
- Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1370 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay
iFlash-hGH by Shenzhen YHLO Biotech Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay.
- LIAISON® hGH — Diasorin Inc.
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- IMMULITE/IMMULITE 1000 Systems Growth Hormone (Recombinant 98/574) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Elecsys hGH — Roche Diagnostics Corp. · Class I
- hGH AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class I
- Elecsys hGH — Roche Diagnostics Corp. · Class I
- hGH AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen YHLO Biotech Co., Ltd.
Sources (2)
- FDA UDI 6f72a787-fcc5-4ecd-8eb2-ad703394d61a 32 fields · synced Jul 14, 2026
- EUDAMED 85ea45d5-9599-4371-b686-34fb37f3f1a7 61 fields · synced Jul 14, 2026