Identity
- Trade Name
- iFlash-Mycoplasma pn. IgG EUDAMEDFDA UDI
- Generic Name
- Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-Mycoplasma pn. IgG EUDAMED
- Model / Reference
- C88003G EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912719199 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270093HJ EUDAMED
- FDA Product Code
- GSA FDA UDI
- EMDN Code
- W0105010802 MYCOPLASMA ANTIBODY ASSAYS EUDAMED
- GMDN Term
- Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3375 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
Yes
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
Category: Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
iFlash-Mycoplasma pn. IgG by Shenzhen YHLO Biotech Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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 396a1d72-0551-4b31-b6dc-29494caf669e 32 fields · synced Jul 18, 2026
- EUDAMED 4b4de9fd-71c1-4843-adbf-fa590601db7f 61 fields · synced Jul 18, 2026