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Axiolab 5
EUDAMEDFDA UDIClass A (EU MDR)
Ref 430037-9011-000Model Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1
Identity
- Trade Name
- Axiolab 5 EUDAMEDZEISS Axiolab FDA UDI
- Generic Name
- Basic light microscope FDA UDI
- Device Name
- Upright microscope EUDAMED
- Model / Reference
- Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1 EUDAMED430037-9011-000 EUDAMEDAxiolab 5 FDA UDI
Identifiers
- Catalog Number
- 430037-9011-000 FDA UDI
- Primary DI / UDI-DI
- 06909262200231 EUDAMEDFDA UDI
- Basic UDI-DI
- 6909262CNA003QD EUDAMED
- Direct Marketing DI
- 06909262200231 EUDAMED
- FDA Product Code
- MTX FDA UDI
- EMDN Code
- W0202050303 OPTICAL LABORATORY MICROSCOPES EUDAMED
- GMDN Term
- Basic 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
Axiolab 5 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 | 6909262CNA003QD | 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 55e332a1-e722-4531-a322-763a299eb193 61 fields · synced Jun 18, 2026
- FDA UDI 26b976f5-7529-44a7-8e20-50f968ce16da 35 fields · synced May 30, 2026