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Axio Vert. A1
EUDAMEDFDA UDIClass A (EU MDR)
Ref 431030-9000-000Model Axiovert 5 / Primovert / Axio Vert.A1/Axiovert 7
Identity
- Trade Name
- Axio Vert. A1 EUDAMEDZEISS Axio Vert FDA UDI
- Generic Name
- Inverted-stage light microscope FDA UDI
- Device Name
- Inverted microscope EUDAMED
- Model / Reference
- Axiovert 5 / Primovert / Axio Vert.A1/Axiovert 7 EUDAMED431030-9000-000 EUDAMEDAxio Vert.A1 FDA UDI
Identifiers
- Catalog Number
- 431030-9000-000 FDA UDI
- Primary DI / UDI-DI
- 06909262200040 EUDAMEDFDA UDI
- Basic UDI-DI
- 6909262CNA002QB EUDAMED
- Direct Marketing DI
- 06909262200040 EUDAMED
- FDA Product Code
- MTX FDA UDI
- EMDN Code
- W0202050303 OPTICAL LABORATORY MICROSCOPES EUDAMED
- GMDN Term
- Inverted-stage light microscope FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 884.6190 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Axio Vert. A1 by Carl Zeiss Suzhou 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 | 6909262CNA002QB | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Suzhou Co., Ltd.
- EUDAMED SRN
- CN-MF-000017606
- Authorised Representative
- Carl Zeiss Microscopy GmbH DE-AR-000024425
Sources (2)
- EUDAMED 6551d53c-bdbf-45d6-b203-3f3bf7d5b7ac 61 fields · synced Jun 19, 2026
- FDA UDI 7c02d3b5-5dce-40e9-9551-6d5dc92362fb 35 fields · synced May 30, 2026