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Dry Immunofluorescence Analyzer
EUDAMEDClass A (EU MDR)
Ref SZY-1100Ref SZY-H01
Identity
- Trade Name
- Dry Immunofluorescence Analyzer EUDAMED
- Device Name
- Dry Immunofluorescence Analyzer EUDAMED
- Model / Reference
- SZY-1100 EUDAMEDSZY-H01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986811988 EUDAMED06974986811995 EUDAMED
- Basic UDI-DI
- 697498681SZYYQ03XL EUDAMED697498681SZYYQ01XG EUDAMED
- Direct Marketing DI
- 06974986811988 EUDAMED06974986811995 EUDAMED
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Dry Immunofluorescence Analyzer by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697498681SZYYQ03XL | Class A | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ab93fe33-9644-4073-8725-0c7013c08307 61 fields · synced Oct 6, 2026
- EUDAMED 450ec5e6-9913-47da-971e-7eb84ed4f5e7 61 fields · synced May 18, 2026