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Immunofluorescence Analyzer
EUDAMEDFDA UDIClass A (EU MDR)
Ref SUPE01L05Model EASY-11Ref SUPE01E05Ref SUPE01105
Identity
- Trade Name
- Immunofluorescence Analyzer EUDAMEDSuperbio Immunofluorescence Analyzer FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- Immunofluorescence Analyzer EUDAMED
- Model / Reference
- EASY-11 EUDAMEDFDA UDISUPE01L05 EUDAMEDSUPE01E05 EUDAMEDSUPE01105 EUDAMED
Identifiers
- Catalog Number
- SUPE01106 FDA UDI
- Primary DI / UDI-DI
- 06974521000099 EUDAMED06974521000082 EUDAMED06974521000068 EUDAMED06974521002246 FDA UDI
- Basic UDI-DI
- 697452100SUPE011TN EUDAMED
- Direct Marketing DI
- 06974521000099 EUDAMED06974521000082 EUDAMED06974521000068 EUDAMED
- 510(k) Number
- K220046 FDA UDI
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Market of Registration
- Ireland 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Immunofluorescence Analyzer by Shenzhen Superbio Technology Co., Ltd. — Class A — 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 | 697452100SUPE011TN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (4)
- EUDAMED d9bb9227-dd72-41f0-a369-5c13c052a7b6 61 fields · synced Aug 3, 2026
- EUDAMED 37a5544b-a1fa-4ba8-8174-fc93b496a18f 61 fields · synced May 18, 2026
- FDA UDI 6b97f724-4179-4d2c-9127-48c9fc8b433f 34 fields · synced May 30, 2026
- EUDAMED 6beb7e71-a492-4718-b65b-a53ad2d77617 61 fields · synced Aug 3, 2026